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Adolescent girls are an important target group for micronutrient interventions particularly in Sub-Saharan Africa where adolescent pregnancy and micronutrient deficiencies are common. When consumed in sufficient amounts and at levels appropriate for the population, fortified foods may be a useful strategy for this group, but little is known about their effectiveness and timing (regarding menarche), particularly in resource-poor environments. We evaluated the effect of consuming multiple micronutrient-fortified biscuits (MMB), sold in the Ghanaian market, 5 d/week for 26 weeks compared with unfortified biscuits (UB) on the micronutrient status of female adolescents. We also explored to what extent the intervention effect varied before or after menarche. Ten2Twenty-Ghana was a 26-week double-blind, randomised controlled trial among adolescent girls aged 10–17 years (n 621) in the Mion District, Ghana. Biomarkers of micronutrient status included concentrations of Hb, plasma ferritin (PF), soluble transferrin receptor (TfR) and retinol-binding protein (RBP), including body-iron stores. Intention-to-treat analysis was supplemented by protocol-specific analysis. We found no effect of the intervention on PF, TfR and RBP. MMB consumption did not affect anaemia and micronutrient deficiencies at the population level. MMB consumption increased the prevalence of vitamin A deficiency by 6·2 % (95 % CI (0·7, 11·6)) among pre-menarche girls when adjusted for baseline micronutrient status, age and height-for-age Z-score, but it decreased the prevalence of deficient/low vitamin A status by −9·6 % (95 % CI (−18·9, −0·3)) among post-menarche girls. Consuming MMB available in the market did not increase iron status in our study, but reduced the prevalence of deficient/low vitamin A status in post-menarcheal girls.

Zinc deficiency poses significant health risks, particularly in low-income settings. This study aims to evaluate the impact of agronomically zinc biofortified (fermented and non-fermented) and post-harvest wheat flour flatbread on zinc status and metabolic health in adolescents and adult women in rural Pakistan. A four-arm triple-blind randomized controlled trial will be conducted in a rural district of Pakistan. Participants (adolescents aged 10-19 and adult women aged 20-40) will be assigned to receive fermented or unfermented high zinc agronomically biofortified wheat flour flatbread, post-harvest zinc-fortified wheat flour flatbread, or low zinc conventional whole wheat flour flatbread. The meal would be served once a day, six days a week for six months. The study aims to enroll 1000 participants and will be analyzed based on the intention-to-treat principle. The trial is registered with number NCT06092515. Primary outcomes will include serum zinc concentration and metabolic markers, while secondary outcomes include anthropometric measurements, blood pressure, and dietary intake. This trial will provide valuable insights into the efficacy of agronomically zinc biofortified wheat flour in improving zinc status and metabolic health. Findings may inform public health strategies to combat zinc deficiency in resource-limited settings.

Micronutrient deficiency is one of the biggest public health concerns in Bangladesh. As per World Health Organisation (WHO) in the 2016 report, 40% women of reproductive age suffer from anaemia. According to the National Micronutrient Survey 2011-2012, 57% women suffer from zinc deficiency. The objective of the present study was to determine the effectiveness of fortified rice (FFR in addressing anaemia and zinc deficiency among vulnerable women. Baseline and endline surveys were conducted among female Vulnerable Group Development (VDG) beneficiaries in five districts in Bangladesh before and after 12 months of FFR distribution. The intervention group received 30 kg FFR; the control group received 30 kg non-FFR for every month from January 2013 to December 2013. The sample sizes were 870 women (435/group) at baseline and 800 (400/group) at endline. Difference-in-difference (DID) was estimated to measure the effect of FFR on anaemia and serum zinc. In the baseline survey, 39% of the FFR group and 34% of the non-FFR group had anaemia. At endline, 34% of women in the FFR group were anaemic compared to 40.7% in the non-FFR group. At endline, prevalence of anaemia was reduced in the FFR group by 4.8% but increased in the non-FFR group by 6.7%. The DID estimation showed the reduction in anaemia after 12 months of FFR consumption was significant (p = 0.035). The DID in mean haemoglobin level after 12 months of FFR consumption was also statistically significant (p = 0.002). Zinc deficiency decreased by 6% in the FFR group at endline, though the DID was not significant. Most of the respondents of the FFR group reported that they received their entitled rice on a regular basis however only half of the non-FFR respondents received every month in 12 months. Anaemia was significantly associated with not consuming fortified rice, geographical region, older age and heavy menstrual bleeding (P<0.05). FFR reduced anaemia and zinc deficiency prevalence. Replacement of regular rice with FFR in the VGD programme is recommended to reduce anaemia among vulnerable groups.

Purpose High prevalence of vitamin D deficiency (VDD) justifies a cost-effective and sustainable strategy to combat VDD in the community. This study was undertaken for the first time to evaluate the efficacy of daily consumption of vitamin D fortified sunflower oil with a meal. Methods This single-blind trial was conducted in two separate institutions: one as intervention (D-fortified sunflower oil) group (DO, n 1  = 39) and the other as control (unfortified sunflower oil) group (SO, n 2  = 33). Participants consumed their lunches cooked either with D-fortified or unfortified cooking sunflower oil (500 IU/30 g) for 12 weeks. Dietary, anthropometric and biochemical assessments were done for all participants before and after the intervention. Results A total of 65 subjects from both sexes aged 32.5 ± 4 years completed the intervention period. Serum 25(OH)D showed a significant increase in DO and a decrease in SO group (8.8 ± 9.3 vs. − 7.4 ± 6.4 ng/mL, p  < 0.001). The rise in serum 25(OH)D in DO group was accompanied by a significant decrease in iPTH (DO: − 10.2 ± 29.4 vs. SO: + 9.2 ± 29.5 pg/mL; p  = 0.009). A significant reduction in weight ( p  = 0.004), BMI ( p  = 0.029), waist girth ( p  < 0.001), serum total cholesterol ( p  = 0.0290) and LDL-C ( p  = 0.010) was observed in DO, as compared with SO group. Conclusions Cooking oil can be considered as an efficacious vehicle for mass fortification program to combat VDD. The improvement of vitamin D status may bring about betterment of certain cardiometabolic risk factors. Registration number Clinicaltrials.gov: NCT03826654.

Background Fortifying human milk contributes to the prevention of postnatal growth failure in preterm infants. Because of the natural variability of human milk, targeted fortification of human milk has been advocated. However, data regarding the efficacy and safety of prolonged targeted fortification are scarce. We aimed to assess the safety of targeted fortification of human milk in preterm infants compared with standard fortification, as well as the effects on infant growth. Methods We conducted an interventional study during hospital stay in healthy very low birth weight preterm infants who were exclusively fed human milk. Pools of human milk collected for 24 h were analysed using mid-infrared transmission spectroscopy. Targeted fortification of human milk was performed by adding macronutrients to native human milk to obtain optimal ratios of fat (4.4 g), carbohydrates (8.8 g), and protein (3 g) per 100 ml. The intervention period lasted 4–7 weeks. Weekly weight and daily growth rates were compared with those of a standardized fortification group of very low birth weight preterm infants who received standard fortified human milk (n = 10). The osmolality as well as the metabolic and gastrointestinal tolerance were monitored. Intergroup differences were evaluated using the Mann–Whitney U-test. Results A total of 10 preterm infants (birth weight 1223 ± 195 g; gestational age 29.1 ± 1.03 weeks) were enrolled and 118 samples of pooled milk were analysed. On average, 1.4 ± 0.1 g of protein, 2.3 ± 0.5 g of carbohydrate, and 0.3 ± 0.1 g of fat per 100 ml were added to the milk. Osmolality values after target fortification were within recommended limits (376 ± 66 mOsml/kg). Weekly weight gain (205.5 g; 95 % CI 177–233 vs 155 g; 95 % CI 132–178; p = 0.025) and daily growth rates (15.7 g/kg/day; 95 % CI 14.5–16.9 vs 12.3 g/kg/day; 95 % CI 10.7–13.9; p = 0.005) were higher in infants receiving target fortification than in infants receiving standardized fortification. The infants receiving targeted fortified milk consumed similar volumes as infants in the standardized fortification group (148 ± 4.5 vs 146 ± 4 ml/kg/day). No signs of either gastrointestinal or metabolic intolerance were observed. Conclusions Target fortification appears to promote growth in very low birth weight preterm infants without any detrimental effects. Trial registration NCT02716337

In recent years, emerging evidence has highlighted the role of vitamin D as an iron absorption enhancer by suppressing hepcidin concentration, albeit with an unclear underlying mechanism. Dietary-based approach in improving iron status has been widely practised, however, there is a scarcity in randomized controlled trials (RCT) to elucidate the effect of vitamin D-fortified juice on iron status recovery. Therefore, this study aims to investigate the effect of an 8-week vitamin D3-fortified fruit juice supplementation on iron status indicators in childbearing-aged women with marginally low iron stores. In a placebo-controlled, double-blind, RCT, a total of 120 women aged between 19-40 with serum ferritin < 20 μg/l and fulfilled the eligibility criteria will be randomized into consuming either vitamin D3-fortified fruit juices containing 4000 IU (100 mcg) (vitamin D) or placebo-fruit juices (placebo) daily for eight weeks. At every 4-week interval, 10 ml fasting blood sample, information on dietary habit and anthropometric measurement will be collected. A mixed model repeated-measures analysis of variance will be performed to determine the effect of the intervention and the interaction with time points for all iron and vitamin D status blood biomarkers. Vitamin D supplementation in food fortification as a novel iron absorption enhancer might be a future and relevant alternative management of iron deficiency as opposed to the oral iron therapy that has poor adherence. Clinicaltrials.gov: registration number NCT04618289, registration date October 28, 2020, protocol ID JKEUPM-2020-033.

Innovative strategies are needed to enhance the nutritional impact of agriculture. Value chain approaches, which use supply chains to add value (usually economic) to products as they move from producers to consumers, can be used to increase access to nutritious foods and improve nutritional status. This study tested whether a dairy value chain could be used to distribute a micronutrient-fortified yoghurt (MNFY) (conditional upon the producer supplying a minimum amount of cow milk/day) to improve hemoglobin and reduce anemia among preschool children in a remote area in Northern Senegal. A cluster randomized control trial was used to compare 204 children (24 to 59 months of age at baseline) from households who received the MNFY coupled to a behavior change communication (BCC) campaign focusing on anemia prevention to 245 children from a control group (receiving BCC only) after one year. Randomization was done at the level of the family concession (households from the same family) (n = 321). Eligible households had a child of the target age and were willing to deliver milk to the dairy factory. Changes in anemia and hemoglobin between groups were assessed using mixed regression models. Anemia prevalence was very high at baseline (80%) and dropped to close to 60% at endline, with no differences between intervention groups. Hemoglobin increased by 0.55 g/dL, 95%CI (0.27; 0.84) more in the intervention compared to the control group after one year, in models that controlled for potentially confounding factors. The impact was greater (0.72 g/dL, 95%CI (0.34; 1.12)) for boys, compared to girls (0.38 g/dL, 95%CI (-0.03; 0.80)). The dairy value chain was a successful strategy to distribute MNFY among pastoralists in Northern Senegal, and increase Hb concentrations among their children. This study is one of the first proofs of concept showing that a nutrition-sensitive agriculture value chain approach can contribute to improved child nutrition in a remote pastoralist population. ClinicalTrials.gov NCT02079961.

Polar lipids constitute an important part of cellular membranes. The mucosal surface of the gastrointestinal tract is a critical barrier between noxious and immunogenic substances in the lumen and the mucosal immune system. We conducted a prospective, double-blinded, randomized, controlled trial in healthy children to evaluate the acceptability, safety, effect on intestinal comfort (constipation), common infectious symptoms (fever, diarrhea, cough), and behavioral regulation of a 4-mo daily intake of 200-mL formula with or without enrichment of the milk fat globule membrane (INPULSE). Data were collected from parental diaries. The primary endpoints for analysis were the number of days with fever, diarrhea, coughing, or constipation. The secondary endpoints were the number of doctor visits, medication intake, number of missed schooldays, acceptability of the test drinks, and safety. The Achenbach System of Empirically Based Assessment, a validated questionnaire to assess behavior, was submitted to parents at the end of the intervention period. Initially 253 children were included, but 71 dropped out (these were subjects with <80% intake or for <90 d). No adverse effects led to the discontinuation. Per-protocol analysis was performed in 97 girls and 85 boys. The group (n = 182) was normally distributed, with a mean age of 4.4 ± 0.9 y. The amount of product taken each day and the acceptability were similar in the intervention and control groups. The number of days with fever (>38.5°C) and the number of short (<3 d) febrile periods were significantly (P < 0.03) decreased in the intervention group (1.7 ± 2.5 vs 2.6 ± 3.1 d) This significant difference in febrile episodes appeared after 6 wk of consecutive intake. Other outcome parameters (diarrhea, constipation, cough, doctor visit, and days of school absence) were similar in the two groups. An analysis of the 169 Achenbach System of Empirically Based Assessment questionnaires (two-tailed t test) showed significant differences in the internal (P < 0.003), external (P < 0.004), and total (P < 0.002) problem scores in favor of the intervention group. Between-subjects effects were highly correlated (internal, P < 0.003; external, P < 0.005; total, P < 0.002, one-way analysis of variance). Regular consumption of formula enriched with a concentrated milk fat membrane (INPULSE) product by preschool children was safe, well tolerated, and, based on per-protocol analysis, is associated with a significant decrease in the number of short febrile episodes and leads to improved behavioral regulation.

Globally, moderate acute malnutrition (MAM) affects approximately 5% of children below five years of age. MAM is a persistent public health problem in Ethiopia. The current approach in Ethiopia for managing MAM is a supplementary feeding program; however, this is only provided to chronically food-insecure areas. The objective of the study was to compare a local-ingredients-based supplement (LIBS) with the standard corn-soy blend plus (CSB+) in treating MAM among children aged 6 to 59 months to test the hypothesis that the recovery rate achieved with LIBS will not be more than 7% worse than that achieved with CSB+. We used an individual randomized controlled non-inferiority trial design with two arms, involving 324 children with MAM aged 6 to 59 months in Wolaita, Southern Ethiopia. One hundred and sixty-two children were randomly assigned to each of the two arms. In the first arm, 125.2 g of LIBS with 8 ml of refined deodorized and cholesterol-free sunflower oil/day was provided. In the second arm, 150 g of CSB+ with 16 ml of refined deodorized and cholesterol-free sunflower oil/day was provided. Each child was provided with a daily ration of either LIBS or CSB+ for 12 weeks. Both intention-to-treat (ITT) and per-protocol (PP) analyses were done. ITT and PP analyses showed non-inferiority of LIBS compared with CSB+ for recovery rate [ITT risk difference = 4.9% (95% CI: -4.70, 14.50); PP risk difference = 3.7% (95% CI: -5.91, 13.31)]; average weight gain [ITT risk difference = 0.10 g (95% CI: -0.33 g, 0.53 g); PP risk difference = 0.04 g (95% CI: -0.38 g, 0.47 g)]; and recovery time [ITT risk difference = -2.64 days (95% CI: -8.40 days, 3.13 days); PP difference -2.17 days (95% CI: -7.97 days, 3.64 days]. Non-inferiority in MUAC gain and length/height gain was also observed in the LIBS group compared with the CSB+ group. LIBS can be used as an alternative to the standard CSB+ for the treatment of MAM. Thus, the potential of scaling up the use of LIBS should be promoted. Pan-African Clinical Trial Registration number: PACTR201809662822990.

Ready-to-use therapeutic food (RUTF) with adequate quality protein is used to treat children with oedematous and non-oedematous severe acute malnutrition (SAM). The plasma amino acid (AA) profile reflects the protein nutritional status; hence, its assessment during SAM treatment is useful in evaluating AA delivery from RUTFs. The objective was to evaluate the plasma AAs during the treatment of oedematous and non-oedematous SAM in community-based management of acute malnutrition (CMAM) using amino acid-enriched plant-based RUTFs with 10% milk (MSMS-RUTF) or without milk (FSMS-RUTF) compared to peanut milk RUTF (PM-RUTF). Plasma AA was measured in a non-blinded, 3-arm, parallel-group, simple randomized controlled trial conducted in Malawi. The RUTFs used for SAM were FSMS-RUTF, MSMS-RUTF or PM-RUTF. A non-inferiority hypothesis was tested to compare plasma AA levels from patients treated with FSMS-RUTF or MSMS-RUTF with those from patients treated with PM-RUTF at discharge. For both types of SAM, FSMS-RUTF and MSMS-RUTF treatments were non-inferior to the PM-RUTF treatment in restoration of the EAA and cystine except that for FSMS-RUTF, methionine and tryptophan partially satisfied the non-inferiority criteria in the oedematous group. Amino-acid-enriched milk-free plant-source-protein RUTF has the potential to restore all the EAA, but it is possible that enrichment with amino acids may require more methionine and tryptophan for oedematous children.