Urine selenium concentration is a useful biomarker for assessing population level selenium status.

Plasma selenium (Se) concentration is an established population level biomarker of Se status, especially in Se-deficient populations. Previously observed correlations between dietary Se intake and urinary Se excretion suggest that urine Se concentration is also a potentially viable biomarker of Se status. However, there are only limited data on urine Se concentration among Se-deficient populations. Here, we test if urine is a viable biomarker for assessing Se status among a large sample of women and children in Malawi, most of whom are likely to be Se-deficient based on plasma Se status. Casual (spot) urine samples (n = 1406) were collected from a nationally representative sample of women of reproductive age (WRA, n =741) and school aged children (SAC, n=665) across Malawi as part of the 2015/16 Demographic and Health Survey. Selenium concentration in urine was determined using inductively coupled plasma mass spectrometry (ICP-MS). Urinary dilution corrections for specific gravity, osmolality, and creatinine were applied to adjust for hydration status. Plasma Se status had been measured for the same survey participants. There was between-cluster variation in urine Se concentration that corresponded with variation in plasma Se concentration, but not between households within a cluster, or between individuals within a household. Corrected urine Se concentrations explained more of the between-cluster variation in plasma Se concentration than uncorrected data. These results provide new evidence that urine may be used in the surveillance of Se status at the population level in some groups. This could be a cost-effective option if urine samples are already being collected for other assessments, such as for iodine status analysis as in the Malawi and other national Demographic and Health Surveys.

The risk of selenium deficiency in Malawi is large and varies over multiple spatial scales.

Selenium (Se) is an essential human micronutrient. Deficiency of Se decreases the activity of selenoproteins and can compromise immune and thyroid function and cognitive development, and increase risks from non-communicable diseases. The prevalence of Se deficiency is unknown in many countries, especially in sub-Saharan Africa (SSA). Here we report that the risk of Se deficiency in Malawi is large among a nationally representative population of 2,761 people. For example, 62.5% and 29.6% of women of reproductive age (WRA, n = 802) had plasma Se concentrations below the thresholds for the optimal activity of the selenoproteins glutathione peroxidase 3 (GPx3; <86.9 ng mL-1) and iodothyronine deiodinase (IDI; <64.8 ng mL-1), respectively. This is the first nationally representative evidence of widespread Se deficiency in SSA. Geostatistical modelling shows that Se deficiency risks are influenced by soil type, and also by proximity to Lake Malawi where more fish is likely to be consumed. Selenium deficiency should be quantified more widely in existing national micronutrient surveillance programmes in SSA given the marginal additional cost this would incur.

Can selenium deficiency in Malawi be alleviated through consumption of agro-biofortified maize flour? Study protocol for a randomised, double-blind, controlled trial.

BACKGROUND: Micronutrient deficiencies including selenium (Se) are widespread in Malawi and potentially underlie a substantial disease burden, particularly among poorer and marginalised populations. Concentrations of Se in staple cereal crops can be increased through application of Se fertilisers - a process known as agronomic biofortification (agro-biofortification) - and this may contribute to alleviating deficiencies. The Addressing Hidden Hunger with Agronomy (AHHA) trial aims to establish the efficacy of this approach for improving Se status in rural Malawi. METHODS: A double-blind, randomised, controlled trial will be conducted in a rural community in Kasungu District, Central Region, Malawi. The hypothesis is that consumption of maize flour agro-biofortified with Se will increase serum Se concentration. We will recruit 180 women of reproductive age (WRA) (20-45 years) and 180 school-age children (SAC) (5-10 years) randomly assigned in a 1:1 ratio to receive either maize flour enriched through agro-biofortification with Se or a control flour not enriched with Se. Households will receive flour (330 g per capita per day) for 12 weeks. The primary outcome is Se concentration in serum (µg/L). Serum will be extracted from venous blood samples drawn at baseline (prior to flour distribution) and end-line. Selenium concentration will be measured by using inductively coupled plasma mass spectrometry. DISCUSSION: Findings will be communicated to policy stakeholders and participating communities and reported in peer-reviewed journals. TRIAL REGISTRATION: The Addressing Hidden Hunger with Agronomy (Malawi) trial is registered (5th March 2019; ISCRTN85899451).

Impact of lipid-based nutrient supplements and corn-soy blend on energy and nutrient intake among moderately underweight 8-18-month-old children participating in a clinical trial.

Nutrition interventions have an effect on growth, energy and nutrient intake, and development, but there are mixed reports on the effect of supplementation of energy-dense foods on dietary intake. This substudy aimed at assessing the effect of supplementation with corn-soy blend (CSB) or lipid-based nutrient supplement (LNS) on energy and nutrient intake in moderately underweight children participating in a clinical trial. A total of 188 children aged 8-18 months participated and received daily either 284 kcal from CSB or 220 kcal from LNS and no supplements (control). An interactive 24-h recall method was used to estimate energy and nutrient intakes in the groups. Total mean energy intake was 548 kcal, 551 kcal and 692 kcal in the control, CSB and LNS groups, respectively (P = 0.011). The mean (95% confidence interval) intake of energy and protein were 144 (37-250; P < 0.001) and 46 (1.5-7.6; P < 0.001) larger, respectively, in the LNS group than among the controls. No significant differences were observed between the control and CSB groups. Energy intake from non-supplement foods was significantly lower in the CSB group compared with the control group, but not in the LNS group, suggesting a lower displacement of non-supplement foods with LNS. Both CSB and LNS supplementation resulted in higher intakes of calcium, iron, zinc and vitamin C compared with controls (all P ≤ 0.001). This study indicates that LNS might be superior to CSB to supplement underweight children as it results in higher energy intake, but this requires confirmation in other settings.

An effectiveness trial showed lipid-based nutrient supplementation but not corn-soya blend offered a modest benefit in weight gain among 6- to 18-month-old underweight children in rural Malawi.

OBJECTIVE: To determine if supplementation with corn-soya blend (CSB) or lipid-based nutrient supplement (LNS) improved the weight gain of moderately underweight infants and children when provided through the national health service. DESIGN: A randomised, controlled, assessor-blinded clinical trial. Infants and children were randomised to receive for 12 weeks an average daily ration of 71 g CSB or 43 g LNS, providing 1188 kJ and 920 kJ, respectively, or no supplement (control). Main outcome was weight gain. Secondary outcomes included changes in anthropometric indices and incidence of serious adverse events. Intention-to-treat analyses were used. SETTING: Kukalanga, Koche, Katema and Jalasi health centres in Mangochi District, rural Malawi. SUBJECTS: Underweight (weight-for-age Z-score <-2) infants and children aged 6-15 months (n 299). RESULTS: Mean weight gain was 630 g, 680 g and 750 g in control, CSB and LNS groups, respectively (P = 0·21). When adjusted for baseline age, children receiving LNS gained on average 90 g more weight (P = 0·185) and their weight-for-length Z-score increased 0·22 more (P = 0·049) compared with those receiving no supplementation. No statistically significant differences were observed between the CSB and control groups in mean weight and length gain. CONCLUSIONS: LNS supplementation provided during the lean season via through the national health service was associated with a modest increase in weight. However, the effect size was lower than that previously reported under more controlled research settings.

The validity of a structured interactive 24-hour recall in estimating energy and nutrient intakes in 15-month-old rural Malawian children.

This study aimed to compare the nutritional intake values among 15-month-old rural Malawian children obtained by weighed food record (WFR) with those obtained by modified 24-hour recall (mod 24-HR), and to develop algorithm for adjusting mod 24-HR values so as to predict mean intake based on WFRs. The study participants were 169 15-month-old children who participated in a clinical trial. Food consumption on one day was observed and weighed (established criterion) by a research assistant to provide the estimates of energy and nutrient intakes. On the following day, another research assistant, blinded to the direct observation, conducted the structured interactive 24-hour recall (24-HR) interview (test method). Paired t-tests and scatter-plots were used to compare intake values of the two methods. The structured interactive 24-HR method tended to overestimate energy and nutrient intakes (each P < 0.001). The regression-through-the-origin method was used to develop adjustment algorithms. Results showed that multiplying the mean energy, protein, fat, iron, zinc and vitamin A intake estimates based on the test method by 0.86, 0.80, 0.68, 0.69, 0.72 and 0.76, respectively, provides an approximation of the mean values based on WFRs.

Developmental outcomes among 18-month-old Malawians after a year of complementary feeding with lipid-based nutrient supplements or corn-soy flour.

The major aim of this trial was to compare the development of 18-month-old infants who received complementary feeding for 1 year either with lipid-based nutrient supplements or micronutrient fortified corn-soy porridge. Our secondary aim was to determine the socio-economic factors associated with developmental outcomes in the same population. A total of 163 six-month-old rural Malawian children were enrolled in a randomized controlled trial where the control population received daily supplementation with 71 g corn-soy flour [Likuni Phala (LP)] (282 kcal) and individuals in the intervention groups received daily either 50 g of lipid-based nutrient supplement (FS50) (264 kcal) or 25 g of lipid-based nutrient supplement (FS25) (130 kcal). The main outcome measures were Griffiths' developmental scores at 0-2 years. Independent comparison of study groups was carried out using analysis of variance (ANOVA) statistics where mean raw scores, quotients, or mental ages were compared. Association of developmental outcome with predictor variables were examined using multiple regression. At 18 months of chronological age, the mean ± standard deviation (SD) mental ages in the LP, FS50, and FS25 groups were 17.9 ± 1.3, 17.9 ± 1.3, and 17.9 ± 1.2 (P > 0.99), respectively. Likewise, the mean raw developmental scores and mean developmental quotients did not differ significantly. Length-for-age z-score gain during the intervention period, and maternal education were associated with developmental outcome at 18 months (P = 0.03 and P = 0.04; respectively). In conclusion, rural Malawian infants receiving 12-month daily supplementation of their diet either with the tested lipid-based nutrient supplements or fortified corn-soy flour have comparable development outcomes by 18 months of age.

Postintervention growth of Malawian children who received 12-mo dietary complementation with a lipid-based nutrient supplement or maize-soy flour.

BACKGROUND: Therapeutic feeding with micronutrient-fortified lipid-based nutrient supplements (LNSs) has proven useful in the rehabilitation of severely malnourished children. We recently reported that complementary feeding of 6-18-mo-old infants with an LNS known as FS50 was associated with improved linear growth and a reduction in the incidence of severe stunting during the supplementation period. OBJECTIVE: Our objective was to assess whether a reduction in stunting seen with 12-mo LNS supplementation was sustained over a subsequent 2-y nonintervention period. DESIGN: One hundred eighty-two 6-mo-old healthy rural Malawian infants were randomly assigned to receive daily supplementation for 12 mo with 71 g of maize-soy flour [likuni phala (LP); control group, 282 kcal] or either 50 g of FS50 (264 kcal; main intervention group), or 25 g of FS25 (130 kcal). Main outcome measures were incidence of severe stunting and mean z score changes in weight-for-age, length-for-age, and weight-for-length during a 36-mo follow-up period. RESULTS: The cumulative 36-mo incidence of severe stunting was 19.6% in LP, 3.6% in FS50, and 10.3% in FS25 groups (P = 0.03). Mean weight-for-age changes were -1.09, -0.76, and -1.22 (P = 0.04); mean length-for-age changes were -0.47, -0.37, and -0.71 (P = 0.10); and mean weight-for-length changes were -1.52, -1.18, and -1.48 (P = 0.27). All differences were more marked among individuals with baseline length-for-age below the median. Differences in length developed during the intervention at age 10-18 mo, whereas weight differences continued to increase after the intervention. CONCLUSIONS: Twelve-month-long complementary feeding with 50 g/d FS50 is likely to have a positive and sustained impact on the incidence of severe stunting in rural Malawi. Half-dose intervention may not have the same effect. This trial was registered at (clinicaltrials.gov) as NCT00131209.

Complementary feeding with fortified spread and incidence of severe stunting in 6- to 18-month-old rural Malawians.

OBJECTIVE: To compare growth and incidence of malnutrition in infants receiving long-term dietary supplementation with ready-to-use fortified spread (FS) or micronutrient-fortified maize-soy flour (likuni phala [LP]). DESIGN: Randomized, controlled, single-blind trial. SETTING: Rural Malawi. PARTICIPANTS: A total of 182 six-month-old infants. INTERVENTION: Participants were randomized to receive 1 year of daily supplementation with 71 g of LP (282 kcal), 50 g of FS (FS50) (256 kcal), or 25 g of FS (FS25) (130 [corrected] kcal). OUTCOME MEASURES: Weight and length gains and the incidences of severe stunting, underweight, and wasting. RESULTS: Mean weight and length gains in the LP, FS50, and FS25 groups were 2.37, 2.47, and 2.37 kg (P = .66) and 12.7, 13.5, and 13.2 cm (P = .23), respectively. In the same groups, the cumulative 12-month incidence of severe stunting was 13.3%, 0.0%, and 3.5% (P = .01), of severe underweight was 15.0%, 22.5%, and 16.9% (P = .71), and of severe wasting was 1.8%, 1.9%, and 1.8% (P > .99). Compared with LP-supplemented infants, those given FS50 gained a mean of 100 g more weight and 0.8 cm more length. There was a significant interaction between baseline length and intervention (P = .04); in children with below-median length at enrollment, those given FS50 gained a mean of 1.9 cm more than individuals receiving LP. CONCLUSION: One-year-long complementary feeding with FS does not have a significantly larger effect than LP on mean weight gain in all infants, but it is likely to boost linear growth in the most disadvantaged individuals and, hence, decrease the incidence of severe stunting.