A Noninferiority Randomized Clinical Trial of the Use of the Smartphone-Based Health Applications IBDsmart and IBDoc in the Care of Inflammatory Bowel Disease Patients.

BACKGROUND: Providing timely follow-up care for patients with inflammatory bowel disease in remission is important but often difficult because of resource limitations. Using smartphones to communicate symptoms and biomarkers is a potential alternative. We aimed to compare outpatient management using 2 smartphone apps (IBDsmart for symptoms and IBDoc for fecal calprotectin monitoring) vs standard face-to-face care. We hypothesized noninferiority of quality of life and symptoms at 12 months plus a reduction in face-to-face appointments in the smartphone app group. METHODS: Inflammatory bowel disease outpatients (previously seen more often than annually) were randomized to smartphone app or standard face-to-face care over 12 months. Quality of life and symptoms were measured quarterly for 12 months. Acceptability was measured for gastroenterologists and patients at 12 months. RESULTS: One hundred people (73 Crohn's disease, 49 male, average age 35 years) consented and completed baseline questionnaires (50 in each group). Intention-to-treat and per-protocol analyses revealed noninferiority of quality of life and symptom scores at 12 months. Outpatient appointment numbers were reduced in smartphone app care (P < 0.001). There was no difference in number of surgical outpatient appointments or number of disease-related hospitalizations between groups. Adherence to IBDsmart (50% perfect adherence) was slightly better than adherence to IBDoc (30% perfect adherence). Good acceptability was reported among most gastroenterologists and patients. CONCLUSIONS: Remote symptom and fecal calprotectin monitoring is effective and acceptable. It also reduces the need for face-to-face outpatient appointments. Patients with mild-to-moderate disease who are not new diagnoses are ideal for this system. CLINICAL TRIAL REGISTRATION NUMBER: ACTRN12615000342516.

Iodine-fortified toddler milk improves dietary iodine intakes and iodine status in toddlers: a randomised controlled trial.

PURPOSE: We aimed to evaluate the effectiveness of consuming iodine-fortified toddler milk for improving dietary iodine intakes and biochemical iodine status in toddlers. METHODS: In a 20-week parallel randomised controlled trial, healthy 12-20-month-old children were assigned to: Fortified Milk [n = 45; iodine-fortified (21.1 µg iodine/100 g prepared drink) cow's milk], or Non-Fortified Milk (n = 90; non-fortified cow's milk). Food and nutrient intakes were assessed with 3-day weighed food records at baseline, and weeks 4 and 20. Urinary iodine concentration (UIC) was measured at baseline and 20 weeks. RESULTS: At baseline, toddlers' median milk intake was 429 g/day. There was no evidence that milk intakes changed within or between the groups during the intervention. Toddlers' baseline geometric mean iodine intake was 46.9 µg/day, and the median UIC of 43 µg/L in the Fortified Milk group and 55 µg/L in the Non-Fortified Milk group indicated moderate and mild iodine deficiency, respectively, with this difference due to chance. During the intervention, iodine intakes increased by 136% (p < 0.001) and UIC increased by 85 µg/L (p < 0.001) in the Fortified Milk group compared to the Non-Fortified Milk group. The 20-week median UIC was 91 µg/L in the Fortified Milk group and 49 µg/L in the Non-Fortified Milk group. CONCLUSIONS: Consumption of ≈ 1.7 cups of iodine-fortified toddler milk per day for 20 weeks can increase dietary iodine intakes and UIC in healthy iodine-deficient toddlers. This strategy alone is unlikely to provide sufficient intake to ensure adequate iodine status in toddlers at risk of mild-to-moderate iodine deficiency.

Protocol for a mixed methods realist evaluation of regional District Health Board groupings in New Zealand.

INTRODUCTION: Achieving effective integration of healthcare across primary, secondary and tertiary care is a key goal of the New Zealand (NZ) Health Strategy. NZ's regional District Health Board (DHB) groupings are fundamental to delivering integration, bringing the country's 20 DHBs together into four groups to collaboratively plan, fund and deliver health services within their defined geographical regions. This research aims to examine how, for whom and in what circumstances the regional DHB groupings work to improve health service integration, healthcare quality, health outcomes and health equity, particularly for Maori and Pacific peoples. METHODS AND ANALYSIS: This research uses a mixed methods realist evaluation design. It comprises three linked studies: (1) formulating initial programme theory (IPT) through developing programme logic models to describe regional DHB working; (2) empirically testing IPT through both a qualitative process evaluation of regional DHB working using a case study design; and (3) a quantitative analysis of the impact that DHB regional groupings may have on service integration, health outcomes, health equity and costs. The findings of these three studies will allow refinement of the IPT and should lead to a programme theory which will explain how, for whom and in what circumstances regional DHB groupings improve service integration, health outcomes and health equity in NZ. ETHICS AND DISSEMINATION: The University of Otago Human Ethics Committee has approved this study. The embedding of a clinician researcher within a participating regional DHB grouping has facilitated research coproduction, the research has been jointly conceived and designed and will be jointly evaluated and disseminated by researchers and practitioners. Uptake of the research findings by other key groups including policymakers, Maori providers and communities and Pacific providers and communities will be supported through key strategic relationships and dissemination activities. Academic dissemination will occur through publication and conference presentations.

Lactating Canadian Women Consuming 1000 µg Folic Acid Daily Have High Circulating Serum Folic Acid Above a Threshold Concentration of Serum Total Folate.

Background: Consumption of high-dose folic acid supplements is common throughout pregnancy and lactation in several countries, including Canada, Brazil, and the United States, and may lead to high levels of circulating unmetabolized folic acid. Objective: The objective of the study was to characterize serum and whole-blood folate forms in Canadian lactating women regularly consuming a daily high-dose folic acid supplement. Methods: One-hundred and seventeen Canadian lactating women aged between 18 and 42 y, with a geometric mean ± SD prepregnancy body mass index (kg/m2) of 23.1 ± 1.2, were enrolled in a vitamin D supplementation trial between 13 and 22 wk of gestation. As part of the trial, the women received a daily multivitamin containing 1000 µg folic acid throughout pregnancy and lactation until 8 wk postpartum. At 8 wk postpartum, serum folate forms, including folic acid and RBC total folate, were determined from nonfasted blood samples. Differences in median folate vitamer concentrations among quintiles of serum total folate status were assessed by the Wald test and quantile regression methods. A breakpoint in the relation between serum folic acid and serum total folate was modeled with the use of the segmented package in R. Results: Median serum total folate concentration among participants was 79.3 nmol/L (5th-95th percentile 30.7-186 nmol/L) and median RBC folate concentration was 2790 nmol/L (5th-95th percentile 1330-4850 nmol/L). There was a breakpoint in the relation between serum total folate and serum folic acid at 78.5 nmol/L (95% CI: 67.9, 89.1 nmol/L), below which serum folic acid was not associated with serum total folate, and above which serum folic acid increased 0.78 nmol/L (95% CI: 0.70, 0.86 nmol/L; P < 0.001) for each 1 nmol/L increase in serum total folate. Conclusions: These data demonstrate the potential for high serum folic acid concentrations proportional to overall folate concentrations in lactating women with serum total folate >80 nmol/L taking high-dose supplemental folic acid. This study was registered at clinicaltrials.gov as NCT01112891.

A randomized double-blind placebo-controlled trial to investigate the effectiveness and safety of a novel green-lipped mussel extract -BioLex® -for managing pain in moderate to severe osteoarthritis of the hip and knee.

BACKGROUND: Extracts from perna canaliculus, the Green Lipped Mussel (GLM) are widely used as a complimentary therapy by patients with osteoarthritis (OA). The current study investigated the potential of a novel GLM formulation as a treatment for OA. A randomized double-blind placebo-controlled trial was undertaken to assess potential impacts on pain and quality of life following 12 weeks of treatment. METHODS: Eighty patients with moderate to severe OA of the hip or knee were randomized to receive either 600 mg of BioLex®-GLM daily or placebo for 12 weeks. Entry criteria included a minimum 100 mm Visual Analogue Scale pain score (VAS) of 30 mm at baseline. The primary outcome was patient reported pain, measured by the Western Ontario and McMasters OA Index (WOMAC) pain subscale and VAS pain scale. Secondary outcomes included: quality of life (OAQol), total WOMAC score, WOMAC -20 responder criteria, and change in medication use over the study period. Participants were assessed at baseline, 12 weeks (end of therapy) and 15 weeks (3-weeks post-intervention). RESULTS: At week 12, there were no significant differences in VAS or WOMAC pain subscale between active and placebo groups, nor significant improvement in the WOMAC-20 responder criteria or OAQol. Joint stiffness (measured by WOMAC-B stiffness) in the GLM group improved compared with placebo (p = 0.046). There was a significant difference in paracetamol use between the GLM treated group and the placebo group after week 12 (p = 0.001). CONCLUSIONS: BioLex® -GLM extract did not confer clinical benefit in moderate to severe OA over the intervention period, however, a significant difference in paracetamol use in the post-intervention period was observed between the BioLex® -GLM group and placebo group. Higher doses and/or longer treatment periods are worthy of future investigation. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry: no. ACTRN12611000256976 .

Do dry roasting, lightly salting nuts affect their cardioprotective properties and acceptability?

PURPOSE: Previous studies have reported improvements in cardiovascular disease (CVD) risk factors with the consumption of raw nuts. However, around one-third of nuts consumed are roasted and salted. Thus, it is important to determine whether roasting and salting nuts affect the health benefits observed with raw nuts. This study aimed to compare the effects of consuming two different forms of hazelnuts on cardiovascular risk factors and acceptance. METHODS: Using a randomised crossover design, 72 participants were asked to consume 30 g/day of either raw or dry roasted, lightly salted hazelnuts for 28 days each. CVD risk factors were measured at the beginning and end of each treatment period. "Desire to consume" and "overall liking" for both forms of hazelnuts were assessed daily using a 150-mm visual analogue scale. RESULTS: Body composition, blood pressure, plasma total and low-density lipoprotein-cholesterol, apolipoprotein A1 and B100, glucose and α-tocopherol concentrations did not differ between forms of hazelnuts (all P ≥ 0.054). High-density lipoprotein (HDL)-cholesterol (P = 0.037) and triacylglycerol (P < 0.001) concentrations were significantly lower following the consumption of dry roasted, lightly salted hazelnuts when compared to the raw hazelnuts. Compared with baseline, consuming both forms of hazelnuts significantly improved HDL-cholesterol and apolipoprotein A1 concentrations, total-C/HDL-C ratio, and systolic blood pressure without significantly changing body composition. Acceptance ratings did not differ between forms of hazelnuts and remained high throughout the study. CONCLUSION: Dry roasting and lightly salting nuts do not appear to negate the cardioprotective effects observed with raw nut consumption, and both forms of nuts are resistant to monotony. Public health messages could be extended to include dry roasted and lightly salted nuts as part of a heart healthy diet.

Iodine Status of New Zealand Elderly Residents in Long-Term Residential Care.

In response to the re-emergence of iodine deficiency in New Zealand, in 2009 the government mandated that all commercially made breads be fortified with iodized salt. There has been no evaluation of the impact of the program on iodine status of the elderly, despite this population group being vulnerable to iodine deficiency or excess. The aim of this study was to describe the iodine status of elderly New Zealanders in residential aged-care homes following the implementation of the bread fortification program. A cross-sectional survey was conducted, involving 309 residents (median age 85 years) from 16 aged-care homes throughout NZ. Information on socio-demographic, anthropometric, dietary and health characteristics were collected. Casual spot urine samples were analysed for urinary iodine concentration (UIC). Blood samples were analysed for serum thyroglobulin, thyroglobulin antibodies, and other biochemical indices. The median UIC (MUIC) of the residents was 72 µg/L, indicating mild iodine deficiency, and 29% had a UIC < 50 µg/L. Median thyroglobulin concentration was 18 ng/mL and 26% had elevated thyroglobulin concentration (>40 ng/mL), suggesting iodine insufficiency. Diuretic use was associated with lower MUIC (p = 0.043). Synthetic thyroxine use was associated with lower odds of having a UIC < 50 µg/L (OR 0.32, p = 0.030)) and lower median thyroglobulin (-15.2 ng/mL, p = 0.001), compared with untreated participants. Frailty was associated with elevated thyroglobulin (p = 0.029), whereas anemia was associated with lower thyroglobulin (p = 0.016). Iodine insufficiency persists in New Zealanders residing in residential aged-care homes despite increasing iodine intake from fortified bread. Research is required to establish optimal iodine intake and status in the elderly.

Nut-enriched bread is an effective and acceptable vehicle to improve regular nut consumption.

PURPOSE: Consuming 30 g of nuts/day is recommended to reduce chronic disease. However, nut consumption appears far from ideal among several populations. A potential strategy to increase consumption is to add nuts to a staple, for example, bread. Whether the health benefits and acceptability of nuts persist in this form is currently unknown. Thus, we examined the effects of consuming three nut-enriched breads on postprandial glycaemia, satiety, gastrointestinal tolerance, dietary intakes, and acceptance. METHODS: In this controlled, crossover study, 32 participants were randomly allocated to receive one of four breads for 8 days each. Three breads contained either 30 g of finely sliced hazelnuts, 30 g semi-defatted hazelnut flour, or 15 g of each (amounts per 120 g bread) and were compared with a control nut-free bread. Blood glucose response was measured over 120 min, along with ratings of gastrointestinal discomfort. Appetite ratings and diet diaries were completed during each treatment period. RESULTS: Area under the blood glucose curve was significantly lower for the nut breads compared to the control bread (all P < 0.001), with no significant differences between the nut breads (all P ≥ 0.130). There were no significant differences in satiety (all P ≥ 0.135) or gastrointestinal symptoms (all P ≥ 0.102) between the breads. Acceptance was highest for the finely sliced hazelnut bread. Furthermore, consuming hazelnut-enriched bread improved diet quality, increasing monounsaturated fat, vitamin E, and dietary fibre intakes. CONCLUSION: Bread appears to be an effective and acceptable vehicle for increasing nut consumption, resulting in improved postprandial glycaemia and diet profiles. Long-term studies are now required.

Effects of anemia at different stages of gestation on infant outcomes.

OBJECTIVES: Maternal anemia is a public health challenge worldwide. The present study aims to explore the effects of maternal anemia at different stages of gestation on postnatal growth and neurobehavioral development in infants. METHODS: A cohort of pregnant Indian women were followed from 13 to 22 wk gestation (i.e., second trimester; n = 211), 29 to 42 wk gestation (i.e., third trimester; n = 178); their infants were followed to ∼3 wk (n = 147) postpartum. Data collected included information on sociodemographic and health-related factors, including anemia (i.e., low hemoglobin status), maternal and infant anthropometric data, and infant neurobehavioral data. A mixed logistic regression model was used to examine the impact of anemia during pregnancy on maternal and infant outcomes (i.e., anthropometric growth parameters and infant neurobehavioral development). RESULTS: The prevalence of maternal anemia was 41% and 55% (P < 0.001), and iron deficiency anemia was 3.6% and 5.6%, respectively, in the second trimester and third trimester. Infants of pregnant women who were not anemic in the second trimester were 0.26 standard deviations (SD) heavier (P = 0.029), 0.50 SD taller (P = 0.001), and had 0.26 SD larger head circumference (P = 0.029) compared with infants of anemic pregnant women. Infants of pregnant women who were not anemic in the third trimester had orientation scores 3.88 higher (P = 0.004) than infants of women who were anemic. CONCLUSIONS: Our findings indicate that maternal anemia in the second trimester of gestation influences postnatal infant growth and underscores the necessity of alleviating anemia in young women in the early stages of gestation.

Iron status of pregnant Indian women from an area of active iron supplementation.

OBJECTIVE: The aim of this study was to investigate the iron status of pregnant tribal women from Ramtek, Nagpur, Maharashtra, India using a combination of indices. METHODS: A community-based observational study was conducted to assess iron status using a convenience sample of pregnant Indian tribal women from Ramtek. Pregnant women were recruited at 13 to 22 wk gestation (first visit; n = 211) and followed to 29 to 42 wk gestation (second visit; n = 177) of pregnancy. Sociodemographic and anthropometric data; iron supplement intake; and blood samples for estimating hemoglobin (Hb), serum ferritin (SF), soluble transferrin receptor (sTfR), and C-reactive protein (CRP) were obtained. RESULTS: The mean (SD) Hb concentration at recruitment was 106 (15) g/L and 106 (14) g/L at the second visit; 41% of the women at recruitment and 55% at second visit were anemic (14% higher, P < 0.001). No women at recruitment and 3.7% at second visit had SF concentration < 15 ng/mL; and 3.3% at recruitment and 3.9% at the second visit had sTfR > 4.4 ng/mL (0.6% higher, P = 0.179). Almost 62% and 71% of pregnant women used iron supplements at both visits, respectively. Iron supplement intake > 7 d in the preceding month improved the Hb concentration by 3.23 g/L and reduced sTfR concentration by 13%; women who were breastfeeding at the time of recruitment had 11% higher SF concentration. CONCLUSIONS: The iron indices suggest that pregnant tribal women of central India, although anemic, had good iron status. Use of iron supplements > 7 d in the preceding month improved iron status; however, non-iron-deficiency anemia persisted in this group.

Vitamin D insufficiency and deficiency: New Zealand general practitioners' perceptions of risk factors and clinical management.

AIMS: To report perceptions regarding vitamin D sources; risk factors, prevention and management of vitamin D deficiency and insufficiency; supplement prescribing practices; patients' enquiries. METHODS: A NSW survey instrument was adapted and pre-tested for NZ conditions. Royal NZ College of General Practitioners online weekly newsletter recipients were provided an electronic survey link. The Medical Council emailed an invitation and online survey link to non-respondents. Hard copy questionnaires were posted to remaining non-respondents. RESULTS: 1089 GPs responded (32% participation). Several sources of information on vitamin D were identified. Sun exposure was considered the main vitamin D source in summer (85%), but in winter (47%) supplements (13%) and food sources were more commonly mentioned. Daily sunlight exposure at low UV times (79%) was identified as the main factor preventing deficiency, followed by high-dose supplements and fortified foods (54% each), winter sun-protection relaxation (48%), daily low-dose supplements (47%), daily sunlight exposure at peak UV times (35%) and relaxation of sun protection, year-round. Patient characteristics prompting alertness to vitamin D status included being housebound or institutionalised (96%), wearing concealing clothing (88%), past history of bone fractures (87%), age over 65 years (84%), poor nutrition (71%) and current bone disease (69%). Insufficiency and deficiency were managed primarily through high-dose supplementation and advice to receive more sunlight. Almost half (47%) had received patient requests for vitamin D testing, and 40% requests for prescribed vitamin D. CONCLUSIONS: Study results should help inform possible educational and other interventions to optimise vitamin D and sun-exposure advice.

Integrating risk context into risk assessments: the Risk Context Scale.

The context in which offenders are released is an important component of conducting risk assessments. A sample of 257 supervised male parolees were followed in the community (M = 870 days) after an initial risk assessment. Drawing on community-based information, the purpose of this study was to evaluate the recently developed Risk Context Scale. Four domains from the Risk Context Scale include Resource Engagement, Social Network Presence, Integration of Care, and Social Stability. Using mediation analysis, an initial static risk probability was altered up to 26% by accounting for risk context. Implications of the present results include a broader explanation of recidivism, offering intervention strategies, and further individualizing risk assessments.

Long-term vitamin D3 supplementation is more effective than vitamin D2 in maintaining serum 25-hydroxyvitamin D status over the winter months.

Public health recommendations do not distinguish between vitamin D2 and vitamin D3, yet disagreement exists on whether these two forms should be considered equivalent. The objective of the present study was to evaluate the effect of a daily physiological dose of vitamin D2 or vitamin D3 on 25-hydroxyvitamin D (25(OH)D) status over the winter months in healthy adults living in Dunedin, New Zealand (latitude 46°S). Participants aged 18-50 years were randomly assigned to 25 µg (1000 IU) vitamin D3 (n 32), 25 µg (1000 IU) vitamin D2 (n 31) or placebo (n 32) daily for 25 weeks beginning at the end of summer. A per-protocol approach, which included ≥ 90 % supplement compliance, was used for all analyses. Serum 25-hydroxyvitamin D3 (25(OH)D3), 25-hydroxyvitamin D2 (25(OH)D2) and parathyroid hormone (PTH) were measured at baseline and at 4, 8, 13 and 25 weeks. Geometric mean total serum 25(OH)D concentrations (sum of 25(OH)D2 and 25(OH)D3) at baseline was 80 nmol/l. After 25 weeks, participants randomised to D2 and placebo had a significant reduction in serum 25(OH)D3 concentrations over the winter months compared with vitamin D3-supplemented participants (both P< 0.001). Supplementation with vitamin D2 increased serum 25(OH)D2 but produced a 9 (95 % CI 1, 17) nmol/l greater decline in the 25(OH)D3 metabolite compared with placebo (P< 0.036). Overall, total serum 25(OH)D concentrations were 21 (95 % CI 14, 30) nmol/l lower in participants receiving vitamin D2 compared with those receiving D3 (P< 0.001), among whom total serum 25(OH)D concentrations remained unchanged. No intervention-related changes in PTH were observed. Daily supplementation of vitamin D3 was more effective than D2; however, the functional consequence of the differing metabolic response warrants further investigation.

Periconceptional bread intakes indicate New Zealand's proposed mandatory folic acid fortification program may be outdated: results from a postpartum survey.

BACKGROUND: In September 2009, a folic acid fortification mandate (135 µg/100 g bread) was to be implemented in New Zealand. However, due to political and manufacturer objection, fortification was deferred until May 2012. Based on estimates of bread consumption derived from a 1997 nationally representative survey, this program was intended to deliver a mean additional intake of 140 µg folic acid/d to women of childbearing age. Little is known about current bread consumption patterns in this target group. The aim of this study was to assess bread consumption among women prior to and during pregnancy with the intent to estimate periconceptional folic acid intakes that would be derived from bread if mandatory fortification were implemented as currently proposed. METHODS: A retrospective survey of 723 postpartum women in hospitals and birthing centres across New Zealand was conducted using a self-administered questionnaire on bread intake prior to and during pregnancy and maternal socio-demographic and obstetric characteristics. RESULTS: Median bread intake before conception (2 slices/d) was below that of previous data upon which the current fortification proposal was modeled (3-4 slices/d). If mandatory fortification is implemented as proposed, only 31% (95% CI = 24%-37%) of childbearing-age women would attain an additional folic acid intake of ≥ 140 µg/d, with a mean of 119 µg/d (95% CI = 107 µg/d-130 µg/d). Based on these data, a fortification level of 160 µg/100 g bread is required to achieve the targeted mean of 140 µg folic acid/d. Nonetheless, under the current proposal additional folic acid intakes would be greatest among the least advantaged segments of the target population: Pacific and indigenous Maori ethnic groups; those with increased parity, lower income and education; younger and single mothers; and women with unplanned pregnancies. Subgroups predicted to derive less than adequate folic acid intakes from the proposed policy were women of Asian descent and those with a postgraduate education. CONCLUSIONS: This study provides insight on the ability of a fortification policy to benefit the groups at highest risk of poor folate intakes in a population. However, bread consumption among the target group of childbearing women appears to have declined since the data used in previous dietary modeling were collected. Thus, it seems prudent to re-model dietary folic acid intakes based on more recent national survey data prior to the implementation of a mandatory folic acid fortification policy.

Delaying mandatory folic acid fortification policy perpetuates health inequalities: results from a retrospective study of postpartum New Zealand women.

BACKGROUND: Internationally, poor periconceptional folic acid uptake has been associated with lower socioeconomic status, minority ethnicity status and unintentional pregnancy. The aim of this study was to describe the extent to which a proposed bread fortification mandate would modify these associations. METHODS: A retrospective survey of postpartum women in hospitals and birthing centres across New Zealand was conducted using a self-administered questionnaire. Details on supplement use and bread intake in the periconceptional period, and maternal socio-demographic and obstetric characteristics were obtained. Criteria for the adequate intake of folic acid through proposed mandatory fortification were the habitual consumption of three or more slices of bread/day (118-150 µg folic acid/day) in the month prior to conception, and during the first trimester of pregnancy. RESULTS: Of the 968 women approached, 758 (78%) agreed to participate. Thirty-three percent of women reported having used folic acid supplements as recommended during the periconceptional period. The proportion of women who would have achieved adequate folic acid intake increased to 59% with mandatory fortification. Socio-demographic predictors of poor folic acid intake from supplements, including younger maternal age, increasing parity, minority ethnicity status, lower education and less income, were rendered either non-significant or appreciably attenuated when mandatory fortification was modelled. Notably, the fully adjusted odds ratio for pregnancy planning was reduced from 17.24 [95% confidence interval (CI): 8.13-36.55] to 2.61 (95% CI: 1.73-3.93; both P< 0.001). CONCLUSIONS: Few women comply with periconceptional folic acid recommendations and thus the maximal prevention of neural tube defects is still far from being attained. Data from this retrospective study demonstrate that mandatory fortification benefits segments of the population less likely to use supplements. This finding has compelling policy implications in countries yet to mandate the folic acid fortification of a staple food.

The effect of maternal iodine status on infant outcomes in an iodine-deficient Indian population.

BACKGROUND: An adequate intake of iodine during pregnancy is essential for the synthesis of maternal thyroid hormones needed to support normal fetal development. This study aimed to assess the iodine status of pregnant tribal Indian women and their infants and to determine the impact of maternal iodine status on infant growth and behavior. METHODS: A prospective, observational study was undertaken to assess the iodine status of tribal pregnant Indian women living in Ramtek, northeast of Nagpur, India. Pregnant women were recruited at 13-22 weeks gestation (n=220), visited a second time at 33-37 weeks gestation (n=183), and again visited at 2-4 weeks postpartum with their infants. Sociodemographic, anthropometric, and biochemical data, including household salt, blood, and urine samples were obtained from pregnant women. Urine samples, anthropometric, and neonatal behavioral data were collected from infants. RESULTS: The median urinary iodine concentration (MUIC) at recruitment (mean gestation=17.5 weeks) of mothers was 106 µg/L, which declined to 71 µg/L at the second visit (mean gestation=34.5 weeks) similar to the postpartum MUIC of 69 µg/L, indicating that these women were iodine deficient. Infant (mean age=2.5 weeks) MUIC was 168 µg/L. Median maternal thyroid stimulating hormone (TSH) and free thyroxine (FT(4)) concentrations at first and second visits were 1.71 and 1.79 mIU/L and 14.4 and 15.4 pmol/L, respectively; 20.0% of women at first visit had TSH >97.5th percentile and 1.4% had FT(4) <2.5th percentile. Salt iodine concentration was a significant predictor of maternal UIC (p<0.001), and postpartum maternal UIC was a significant predictor of infant UIC (p<0.001). For every pmol/L increase in maternal FT(4) concentration at first visit, both infant weight-for-age Z-score and length-for-age Z-score increased by 0.05 units. There was no relationship between maternal UIC, FT(4), or TSH at first visit and neonatal behavior. CONCLUSIONS: Despite three quarters of the women in this study having access to adequately iodized salt (i.e., >15 ppm), these pregnant tribal Indian women were iodine deficient. Increasing the iodine content of salt deemed adequately iodized and iodine supplementation are two strategies that might improve the iodine status of these pregnant women and, consequently, the growth of their infants.

Are pregnant women in New Zealand iodine deficient? A cross-sectional survey.

Severe iodine deficiency in pregnancy can result in cretinism. There is growing concern that less severe iodine deficiency may also affect fetal growth and development. A handful of prior small New Zealand studies focussed on pregnant women living in Dunedin. This study utilised biochemical, clinical and dietary indices to assess iodine status of 170 women living throughout New Zealand. The median urinary iodine concentration (UIC) of the women was 38 µg/L, well below the 150 µg/L cut-off value that indicates adequate iodine status; 7% of women had goitre. Not surprisingly, iodine intake was also low at 48 µg/day. The majority of women had TSH and FT4 concentrations within pregnant reference ranges, suggesting that despite the low UIC observed in these women, thyroid hormone production appeared unaffected.

Vitamin D-fortified milk achieves the targeted serum 25-hydroxyvitamin D concentration without affecting that of parathyroid hormone in New Zealand toddlers.

For young children, the level of vitamin D required to ensure that most achieve targeted serum 25-hydroxyvitamin D [25(OH)D] ≥50 nmol/L has not been studied. We aimed to investigate the effect of vitamin D-fortified milk on serum 25(OH)D and parathyroid hormone (PTH) concentrations and to examine the dose-response relationship between vitamin D intake from study milks and serum 25(OH)D concentrations in healthy toddlers aged 12-20 mo living in Dunedin, New Zealand (latitude 46°S). Data from a 20-wk, partially blinded, randomized trial that investigated the effect of providing red meat or fortified toddler milk on the iron, zinc, iodine, and vitamin D status in young New Zealand children (n = 181; mean age 17 mo) were used. Adherence to the intervention was assessed by 7-d weighed diaries at wk 2, 7, 11, 15, and 19. Serum 25(OH)D concentration was measured at baseline and wk 20. Mean vitamin D intake provided by fortified milk was 3.7 µg/d (range, 0-10.4 µg/d). After 20 wk, serum 25(OH)D concentrations but not PTH were significantly different in the milk groups. The prevalence of having a serum 25(OH)D <50 nmol/L remained relatively unchanged at 43% in the meat group, whereas it significantly decreased to between 11 and 15% in those consuming fortified study milk. In New Zealand, vitamin D intake in young children is minimal. Our findings indicate that habitual consumption of vitamin D-fortified milk providing a mean intake of nearly 4 µg/d was effective in achieving adequate year-round serum 25(OH)D for most children.

Long-term effect of low-dose folic acid intake: potential effect of mandatory fortification on the prevention of neural tube defects.

BACKGROUND: Understanding the full effect of chronic low-dose folic acid is important in interpreting the effect of the mandatory folic acid fortification program in North America. OBJECTIVE: We aimed to describe the rate of attainment and steady state (plateau) of red blood cell (RBC) folate in response to long-term intake of 140 µg (designed to mimic fortification) and 400 µg (recommended dose for the primary prevention of neural tube defects) folic acid/d in reproductive-aged women living in a country with minimal fortification. DESIGN: On the basis of pharmacokinetics principles, it was recently proposed that a steady state should be reached after 40 wk. Thus, 144 women aged 18-40 y were randomly assigned to receive a daily folic acid supplement of 140 (n = 49) or 400 (n = 48) µg or placebo (n = 47) for 40 wk. RBC folate was measured at baseline and at 6, 12, 29, and 40 wk. RESULTS: After 40 wk, RBC folate did not reach a plateau in either treatment group. Kinetic modeling of the data indicated that RBC folate would approximately double from 779 to 1356 nmol/L in response to 140 µg folic acid/d with only ≈50% of model-estimated steady state conditions achieved at 40 wk. An average RBC folate concentration of 1068 nmol/L after 12 wk of supplementation with 400 µg folic acid/d was readily achieved at 36 wk after continuous intake of 140 µg/d. CONCLUSION: Our model shows the considerable length of time required to attain the full effect of low-dose folic acid, which suggests that 140 µg folic acid/d could be as effective as 400 µg folic acid/d taken during the periconceptional period if given sufficient time. This trial is registered at www.anzctr.org.au as ACTRN12609000215224.

Folate status of reproductive age women and neural tube defect risk: the effect of long-term folic acid supplementation at doses of 140 µg and 400 µg per day.

Primary prevention of most folate-responsive neural tube defects (NTDs) may not require 400 µg folic acid/day but may be achieved by attaining a high maternal folate status. Using RBC folate ≥906 nmol/L as a marker for NTD risk reduction, the study aimed to determine the change in blood folate concentrations in reproductive age women in response to long-term folic acid supplementation at 400 µg/day and 140 µg/day (dose designed to mimic the average daily folic acid intake received from New Zealand's proposed mandatory bread fortification program). Participants were randomly assigned to a daily folic acid supplement of 140 µg (n = 49), 400 µg (n = 48) or placebo (n = 47) for 40 weeks. RBC folate concentrations were measured at baseline, and after 6, 12, 29 and 40 weeks. At 40 weeks, the overall prevalence of having a RBC folate <906 nmol/L decreased to 18% and 35% in the 400 µg and 140 µg groups, respectively, while remaining relatively unchanged at 58% in the placebo group. After 40 weeks, there was no evidence of a difference in RBC folate between the two treatment groups (P = 0.340), nor was there evidence of a difference in the odds of a RBC folate <906 nmol/L (P = 0.078). In conclusion, the average daily intake of folic acid received from the proposed fortification program would increase RBC folate concentrations in reproductive age women to levels associated with a low risk of NTDs.