Daily Maternal Lipid-Based Nutrient Supplementation with 20 mg Iron, Compared with Iron and Folic Acid with 60 mg Iron, Resulted in Lower Iron Status in Late Pregnancy but Not at 6 Months Postpartum in Either the Mothers or Their Infants in Bangladesh.

Background: Maternal anemia and iron deficiency are prevalent in low- and middle-income countries. Objective: We aimed to determine the effects of lipid-based nutrient supplements for pregnant and lactating women (LNS-PL) on hemoglobin (Hb), anemia, and iron status (nonprimary outcomes) at 36 weeks of gestation (women) and 6 mo postpartum (women and infants). Methods: The Rang-Din Nutrition Study, a cluster-randomized effectiveness trial, enrolled 4011 Bangladeshi pregnant women at ≤20 weeks of gestation to receive either daily LNS-PL (20 mg Fe) during pregnancy and the first 6 mo postpartum, or iron and folic acid (IFA, 60 mg Fe + 400 µg folic acid) daily during pregnancy and every other day during the first 3 mo postpartum. Biochemical measurements from a subsample of women (n = 1128) and their infants (n = 1117) included Hb (g/L), serum ferritin (µg/L), and soluble transferrin receptor (sTfR; mg/L). Anemia was defined as maternal Hb <110 g/L at 36 weeks of gestation, <120 g/L at 6 mo postpartum, or infant Hb <105 g/L; iron deficiency (ID) was defined as ferritin <12 µg/L or elevated sTfR (>8.3 mg/L for women and >11 mg/L for infants). Results: Compared with the IFA group, women in the LNS-PL group had lower ferritin (-6.2 µg/L; P < 0.001) and higher sTfR concentrations (+0.5 mg/L; P < 0.001), and higher risk of ID (OR = 1.93; P < 0.05) at 36 weeks of gestation but not at 6 mo postpartum, whereas no consistent differences were observed for Hb or anemia. Among infants at 6 mo, there were no group differences except for a lower risk of elevated sTfR (OR = 0.61; P < 0.05) in the LNS-PL group than in the IFA group. Conclusions: Provision of LNS-PL including a lower dose of iron than what is recommended during pregnancy resulted in differences in maternal iron status in late pregnancy that disappeared by 6 mo postpartum, and caused no undesirable effects regarding anemia or iron status of infants. This trial was registered at clinicaltrials.gov as NCT01715038.

Prenatal Lipid-Based Nutrient Supplements Do Not Affect Pregnancy or Childbirth Complications or Cesarean Delivery in Bangladesh: A Cluster-Randomized Controlled Effectiveness Trial.

Background: Pregnancy and childbirth complications and cesarean delivery are common in Bangladesh.Objective: We evaluated the effect of lipid-based nutrient supplements for pregnant and lactating women (LNS-PL) on pregnancy and childbirth complications and cesarean delivery.Methods: We conducted the Rang-Din Nutrition Study, a cluster-randomized controlled effectiveness trial within a community health program in rural Bangladesh. We enrolled 4011 pregnant women in early pregnancy. Women in 48 clusters received iron and folic acid (IFA; 60 mg Fe + 400 µg folic acid/d) and women in 16 clusters received LNS-PL (20 g/d, 118 kcal) containing essential fatty acids and 22 vitamins and minerals. Pregnancy and childbirth complications and the cesarean delivery rate were secondary outcomes of the study.Results: Women in the LNS-PL group did not differ significantly from the IFA group with respect to mean systolic blood pressure at 36 wk gestation (113 and 112 mm Hg; P = 0.17), diastolic blood pressure at 36 wk gestation (68.9 and 68.7 mmHg; P = 0.88), or mean total number of pregnancy and childbirth complications (0.32 and 0.31; P = 0.86). They also did not differ significantly with respect to the prevalence of high blood pressure at 36 wk (1.74% and 2.03%; P = 0.62), antepartum hemorrhage (0.83% and 1.39%; P = 0.21), prolonged labor (8.34% and 8.79%; P = 0.68), early rupture of membranes (9.30% and 8.45%; P = 0.43), convulsions (1.57% and 1.08%; P = 0.24), high blood pressure in labor (1.54% and 1.19%; P = 0.46), obstructed labor (2.83% and 2.91%; P = 0.90), any complications during pregnancy or childbirth (35.9% and 37.1%; P = 0.64), episiotomy (6.31% and 6.44%; P = 0.90), or cesarean delivery (15.6% and 14.2%; P = 0.48).Conclusion: Compared with IFA, antenatal LNS-PL did not increase or decrease pregnancy and childbirth complications or cesarean delivery among women in rural Bangladesh. This trial was registered at clinicaltrials.gov as NCT01715038.

Maternal and Child Supplementation with Lipid-Based Nutrient Supplements, but Not Child Supplementation Alone, Decreases Self-Reported Household Food Insecurity in Some Settings.

Background: It is unknown whether self-reported measures of household food insecurity change in response to food-based nutrient supplementation.Objective: We assessed the impacts of providing lipid-based nutrient supplements (LNSs) to women during pregnancy and postpartum and/or to their children on self-reported household food insecurity in Malawi [DOSE and DYAD trial in Malawi (DYAD-M)], Ghana [DYAD trial in Ghana (DYAD-G)], and Bangladesh [Rang-Din Nutrition Study (RDNS) trial].Methods: Longitudinal household food-insecurity data were collected during 3 individually randomized trials and 1 cluster-randomized trial testing the efficacy or effectiveness of LNSs (generally 118 kcal/d). Seasonally adjusted Household Food Insecurity Access Scale (HFIAS) scores were constructed for 1127 DOSE households, 732 DYAD-M households, 1109 DYAD-G households, and 3671 RDNS households. The impact of providing LNSs to women during pregnancy and the first 6 mo postpartum and/or to their children from 6 to 18-24 mo on seasonally adjusted HFIAS scores was assessed by using negative binomial models (DOSE, DYAD-M, and DYAD-G trials) and mixed-effect negative binomial models (RDNS trial).Results: In the DOSE and DYAD-G trials, seasonally adjusted HFIAS scores were not different between the LNS and non-LNS groups. In the DYAD-M trial, the average household food-insecurity scores were 14% lower (P = 0.01) in LNS households than in non-LNS households. In the RDNS trial, compared with non-LNS households, food-insecurity scores were 17% lower (P = 0.02) during pregnancy and the first 6 mo postpartum and 15% lower (P = 0.02) at 6-24 mo postpartum in LNS households.Conclusions: The daily provision of LNSs to mothers and their children throughout much of the "first 1000 d" may improve household food security in some settings, which could be viewed as an additional benefit that may accrue in households should policy makers choose to invest in LNSs to promote child growth and development. These trials were registered at clinicaltrials.gov as NCT00945698 (DOSE) NCT01239693 (DYAD-M), NCT00970866 (DYAD-G) and NCT01715038 (RDNS).

Daily Consumption of Lipid-Based Nutrient Supplements Containing 250 µg Iodine Does Not Increase Urinary Iodine Concentrations in Pregnant and Postpartum Women in Bangladesh.

Background: Maternal iodine deficiency during pregnancy and lactation is common in Bangladesh.Objective: We evaluated the effect of lipid-based nutrient supplements for pregnant and lactating women (LNS-PL) on urinary iodine concentration (UIC).Methods: We conducted a cluster-randomized controlled effectiveness trial in which we enrolled 4011 pregnant women at ≤20 gestational weeks. Women in 48 clusters received iron and folic acid (IFA; 60 mg Fe/d + 400 µg folic acid/d) and women in 16 clusters received LNS-PL (20 g/d, 118 kcal) containing 22 vitamins and minerals (including 250 µg I). We randomly selected a subsample of 1159 women for repeated urine sample collection, i.e., at enrollment, at 36 wk of gestation, and at 6 mo postpartum, for UIC analysis, a secondary outcome of the trial.Results: The geometric mean UIC at 36 wk of gestation and at 6 mo postpartum did not differ significantly between the IFA and LNS-PL groups. The median (quartile 1, quartile 3) UIC at 36 wk was 27.4 µg/L (16.9, 52.7 µg/L) in the IFA group and 30.2 µg/L (17.7, 56.6 µg/L) in the LNS-PL group; at 6 mo, these were 23.0 µg/L (10.0, 45.9 µg/L) in the IFA group and 22.2 µg/L (9.1, 50.4 µg/L) in the LNS-PL group.Conclusion: Daily consumption of LNS-PL containing 250 µg I did not increase the UICs of pregnant and lactating women in Bangladesh. Iodine from lipid-based nutrient supplements may have been stored in the thyroid gland or secreted in breast milk instead of being excreted in urine. Additional research that uses other biomarkers of iodine status is needed to determine how to meet the iodine requirements of pregnant and lactating women in Bangladesh and similar settings. This trial was registered at clinicaltrials.gov as NCT01715038.

Eating down or simply eating less? The diet and health implications of these practices during pregnancy and postpartum in rural Bangladesh.

OBJECTIVE: To: (i) determine the prevalence of self-reported eating less and eating down during early and late pregnancy and postpartum, and explore risk factors associated with eating less; (ii) examine the association between eating less and diet quality; and (iii) determine the association between eating less and weight gain during pregnancy. DESIGN: Data were collected longitudinally from a cohort of women participating in a community health programme. Diet was assessed at three time points (≤20 weeks' gestation, 36 weeks' gestation, 6 months' postpartum), body weight was measured during study enrolment (≤20 weeks' gestation) and at 36 weeks' gestation, and information about the woman and her household was collected at enrolment. SETTING: The Rang-Din Nutrition Study in the Rangpur and Dinajpur districts of Bangladesh. SUBJECTS: Women (n 4011). RESULTS: The prevalence of self-reported eating less differed by time point (75·9 % in early pregnancy, 38·8 % in late pregnancy, 7·4 % postpartum; P<0·001). The most common reason for eating less across all time periods was food aversion or loss of appetite. Women who reported eating less in late pregnancy had consumed animal-source foods less frequently in the preceding week than women who reported eating more (mean (sd): 11·7 (7·4) v. 14·8 (9·2) times/week; P<0·001) and had lower weekly weight gain than women who reported eating more (mean (se): 0·27 (0·004) v. 0·33 (0·004) kg/week; P<0·001). CONCLUSIONS: Eating less has negative implications with respect to diet quality and pregnancy weight gain in this context.

Adherence to recommendations on lipid-based nutrient supplement and iron and folic acid tablet consumption among pregnant and lactating women participating in a community health programme in northwest Bangladesh.

Limited knowledge exists on sustained adherence to small-quantity lipid-based nutrient supplements for pregnant and lactating women (LNS-PL) and how this compares with that of other prenatal supplements. To address these gaps, a random subsample of women (n = 360) during pregnancy, early (6- to 12-week post-partum) and late (12- to 24-week post-partum) lactation, from an ongoing effectiveness trial in Bangladesh, was selected for in-home interviews about LNS-PL or iron/folic acid (IFA) use and preferences. Prevalence of high adherence (≥70% of the recommendation) based on self-reported supplement consumption was 67%, 68% and 81% among LNS-PL recipients during pregnancy, early and late lactation, and was 87% and 71% among IFA recipients during pregnancy and early lactation, respectively (P = 0.044). Programmatic factors (e.g. distribution and visits by programme staff) were consistently statistically significantly associated with reported high adherence. Among LNS-PL recipients, high overall supplement acceptability score [odds ratio (OR): 8.62; 95% confidence interval (CI) 3.53, 20.83] and use of reminder techniques (OR: 4.41; 95%CI 1.65, 11.76) were positively associated, and reported vomiting at enrollment was negatively associated (OR: 0.34; 95%CI 0.14, 0.80), with reported high adherence. Selected women (n = 16) and key informants (n = 18) participated in in-depth interviews about perceptions and acceptability of LNS-PL. Women perceived benefits of taking LNS-PL, but some faced barriers to consumption including aversion to odour and taste during pregnancy, forgetfulness and disruptions in supply. To achieve high adherence, results from this study suggest that maternal supplementation programmes should focus on programmatic barriers and consider incorporating reminder techniques. Organoleptic acceptability of LNS-PL, particularly during pregnancy, may also need to be addressed.

Prenatal Lipid-Based Nutrient Supplements Affect Maternal Anthropometric Indicators Only in Certain Subgroups of Rural Bangladeshi Women.

BACKGROUND: Maternal undernutrition and low macro- and micronutrient intake and weight gain during pregnancy have been reported in Bangladesh. OBJECTIVE: We aimed to determine the effects of lipid-based nutrient supplements for pregnant and lactating women (LNS-PL) on weight gain and midupper arm circumference (MUAC) during pregnancy. METHODS: The Rang-Din Nutrition Study, a cluster-randomized effectiveness trial conducted in Bangladesh, enrolled 4011 pregnant women at ≤20 wk gestation who received either 60 mg Fe + 400 µg folic acid/d or 20 g LNS-PL/d (118 kcal) containing essential fatty acids and vitamins and minerals until delivery. At 36 wk gestation, women were interviewed at home and then attended a follow-up examination at local clinics (n = 2877), where anthropometric measurements were taken. RESULTS: No significant differences between intervention groups in maternal weight gain per week, low weight gain per week, or MUAC at 36 wk gestation were observed in the full sample. However, among multiparous women aged ≥25 y, those in the LNS-PL group gained 34 g/wk more than their counterparts in the iron and folic acid (IFA) group (P = 0.001), whereas no differences were seen in the other parity/age subgroups. Women aged ≥25 y in the LNS-PL group had a 0.4-cm greater MUAC than their counterparts in the IFA group (P = 0.003); no significant differences were observed in the other age groups. Among women whose height at baseline was in the lowest quartile of the distribution, those in the LNS-PL group had a 0.1-0.3-cm greater MUAC at 36 wk gestation than those in the IFA group (P = 0.004-0.014). CONCLUSIONS: Lipid-based nutrient supplements provided during pregnancy did not affect maternal anthropometric indicators in the overall sample but increased MUAC among women aged ≥25 y and those with lower stature and weight gain among multiparous women aged ≥25 y. This trial was registered at clinicaltrials.gov as NCT01715038.

Lipid-based nutrient supplements for pregnant women reduce newborn stunting in a cluster-randomized controlled effectiveness trial in Bangladesh.

BACKGROUND: Maternal undernutrition and newborn stunting [birth length-for-age z score (LAZ) <-2] are common in Bangladesh. OBJECTIVE: The objective was to evaluate the effect of lipid-based nutrient supplements for pregnant and lactating women (LNS-PLs) on birth outcomes. DESIGN: We conducted a cluster-randomized effectiveness trial (the Rang-Din Nutrition Study) within a community health program in rural Bangladesh. We enrolled 4011 pregnant women at ≤20 gestational weeks; 48 clusters received iron and folic acid (IFA; 60 mg Fe + 400 µg folic acid) and 16 clusters received LNS-PLs (20 g/d, 118 kcal) containing essential fatty acids and 22 vitamins and minerals. Both of the supplements were intended for daily consumption until delivery. Primary outcomes were birth weight and length. RESULTS: Infants in the LNS-PL group had higher birth weights (2629 ± 408 compared with 2588 ± 413 g; P = 0.007), weight-for-age z scores (-1.48 ± 1.01 compared with -1.59 ± 1.02; P = 0.006), head-circumference-for-age z scores (HCZs; -1.26 ± 1.08 compared with -1.34 ± 1.12; P = 0.028), and body mass index z scores (-1.57 ± 1.05 compared with -1.66 ± 1.03; P = 0.005) than those in the IFA group; in adjusted models, the differences in length (47.6 ± 0.07 compared with 47.4 ± 0.04 cm; P = 0.043) and LAZ (-1.15 ± 0.04 compared with -1.24 ± 0.02; P = 0.035) were also significant. LNS-PLs reduced the risk of newborn stunting (18.7% compared with 22.6%; RR: 0.83; 95% CI: 0.71, 0.97) and small head size (HCZ <-2) (20.7% compared with 24.9%; RR: 0.85; 95% CI: 0.73, 0.98). The effects of LNS-PL on newborn stunting were greatest in infants born before a 10-wk interruption in LNS-PL distribution (n = 1301; 15.7% compared with 23.6%; adjusted RR: 0.69; 95% CI: 0.53, 0.89) and in infants born to women ≤24 y of age or with household food insecurity. CONCLUSION: Prenatal lipid-based nutrient supplements can improve birth outcomes in Bangladeshi women, especially those at higher risk of fetal growth restriction. This trial was registered at clinicaltrials.gov as NCT01715038.