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

ABSTRACT: 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 ?g 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.

SUBMITTER: Mridha MK

PROVIDER: S-EPMC6443293 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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

Mridha Malay K MK Matias Susana L SL Chaparro Camila M CM Paul Rina R RR Hussain Sohrab S Vosti Stephen A SA Harding Kassandra L KL Cummins Joseph R JR Day Louise T LT Saha Stacy L SL Peerson Janet M JM Dewey Kathryn G KG

The American journal of clinical nutrition 20151125 1

<h4>Background</h4>Maternal undernutrition and newborn stunting [birth length-for-age z score (LAZ) <-2] are common in Bangladesh.<h4>Objective</h4>The objective was to evaluate the effect of lipid-based nutrient supplements for pregnant and lactating women (LNS-PLs) on birth outcomes.<h4>Design</h4>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; 4 ...[more]

PMID: 26607935

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Project description:UnlabelledSmall-quantity lipid-based nutrient supplements (SQ-LNS) are promising home fortification products, but the optimal zinc level needed to improve growth and reduce morbidity is uncertain. We aimed to assess the impact of providing SQ-LNS with varied amounts of zinc, along with illness treatment, on zinc-related outcomes compared with standard care. In a placebo-controlled, cluster-randomized trial, 34 communities were stratified to intervention (IC) or non-intervention cohorts (NIC). 2435 eligible IC children were randomly assigned to one of four groups:1) SQ-LNS without zinc, placebo tablet; 2) SQ-LNS containing 5mg zinc, placebo tablet; 3) SQ-LNS containing 10mg zinc, placebo tablet; or 4) SQ-LNS without zinc and 5mg zinc tablet from 9–18 months of age. During weekly morbidity surveillance, oral rehydration salts were provided for reported diarrhea and antimalarial therapy for confirmed malaria. Children in NIC (n = 785) did not receive SQ-LNS, tablets, illness surveillance or treatment. At 9 and 18 months, length, weight and hemoglobin were measured in all children. Reported adherence was 97 ± 6% for SQ-LNS and tablets. Mean baseline hemoglobin was 89 ± 15g/L. At 18 months, change in hemoglobin was greater in IC than NIC (+8 vs -1g/L, p<0.0001), but 79.1% of IC were still anemic (vs. 91.1% in NIC). Final plasma zinc concentration did not differ by group. During the 9-month observation period, the incidence of diarrhea was 1.10 ± 1.03 and of malaria 0.54 ± 0.50 episodes per 100 child-days, and did not differ by group. Length at 18 months was significantly greater in IC compared to NIC (77.7 ± 3.0 vs. 76.9 ± 3.4 cm; p<0.001) and stunting prevalence was significantly lower in IC (29.3%) than NIC (39.3%; p<0.0001), but did not differ by intervention group within IC. Wasting prevalence was also significantly lower in IC (8.7%) than in NIC (13.5%; p = 0.0003). Providing SQ-LNS daily with or without zinc, along with malaria and diarrhea treatment, significantly increased growth and reduced stunting, wasting and anemia prevalence in young children.Trial registrationClinicalTrials.gov NCT00944281.

Project description:BACKGROUND:There is an increasing interest in use of food supplements to prevent childhood stunting, however the evidence on the process indicators is scarce. We in this study explore the barriers to the effective implementation of food supplementation programs and the possible mitigation strategies which can guide the design of future programs. METHODS:We undertook a process evaluation of a stunting prevention food supplementation pilot program in rural Pakistan that distributed Wheat Soy Blend (WSB) to pregnant & lactating women, and Lipid-based Nutrient Supplement (LNS) and micronutrient powder (MNP) to < 5 years children. We used a mixed methods approach through a quantitative survey of 800 households and conducted 18 focused group discussion (FGDs) (with male and female caregivers), 4 FGDs (with Community Health Workers (CHWs)) and 22 key informant interviews (with district stakeholders) to evaluate the community side factors affecting uptake through five parameters: value, acceptability, receipt of supplement, usage and correct dosage. RESULTS:The findings show that proportionately few beneficiaries consumed the full dose of supplements, despite reasonable knowledge amongst caregivers. Sharing of supplements with other household member was common, and the full monthly stock was usually not received. Qualitative findings suggest that caregivers did not associate food supplements with stunting prevention. WSB was well accepted as an extra ration, LNS was popular due its chocolaty taste and texture, whereas MNP sprinkles were perceived to be of little value. The cultural food practices led to common sharing, whereas interaction with CHWs was minimal for nutrition counselling. Qualitative findings also indicate CHWs related programmatic constraints of low motivation, multi-tasking, inadequate counselling skills and weak supervision. CONCLUSION:We conclude that the community acceptability of food supplements does not translate into optimal consumption. Hence a greater emphasis is needed on context specific demand creation and focusing on the supply side constraints with improved logistical planning, enhanced motivation and supervision of community workers with involvement of multiple stakeholders. While, similar studies are needed in varying contexts to help frame universal guidelines. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02422953 . Registered on April 22, 2015.

Project description:IntroductionIron deficiency is the most prevalent micronutrient deficiency in pregnancy globally responsible for nearly 120 000 maternal deaths per year and a fifth of maternal mortality. Over 46% of pregnant women in Africa and 62% of pregnant women in Kenya are anaemic. Anaemia has severe economic and health consequences. Daily iron and folic acid supplementation (IFAS) is an efficacious strategy recommended in pregnancy to reduce the risk of anaemia and improve maternal and neonatal survival. However, most pregnant women do not consume IFAS as recommended. Limited knowledge on IFAS, its benefits and its connection with anaemia, and mitigation of its side effects lead to poor consumption. The main objective of this trial is to determine the effectiveness of public health education on uptake of antenatal IFAS.Methods and analysisA stepped wedge cluster randomised trial with antenatal clinics as units of randomisation. Twelve clusters will be randomised to receive the intervention and levels of IFAS uptake compared with preintervention period. The 9-month trial will enrol 1205 pregnant women. The primary outcome will be the proportion of pregnant women effectively taking up IFAS measured through self-reports, residual pill count and inspection of pill reminder cards. Routine clinical data on haemoglobin counts and fetal growth monitoring will also be used. Descriptive and bivariate analysis will be conducted in Stata using Pearson's χ2 test for association, and multivariate logistic regression to identify determinants of uptake. The potential public health benefits will be estimated using the number needed to treat and the preventable fraction.Ethics and disseminationEthical approval was granted by Kenyatta University Ethics Review Committee (PKU/2443/11575). The research permit is obtained from Kenya National Commission for Science, Technology and Innovation (NACOSTI/P/22/16168). Findings will be disseminated through peer-reviewed publications and public health conferences.Trial registration numberPACTR202202775997127.

Project description:BackgroundPregnant women in Malawi are at risk of selenium deficiency, which can have adverse effects on pregnancy outcomes. Interventions for improving selenium status are needed.ObjectivesTo assess the effect of provision of small-quantity lipid-based nutrient supplements (SQ-LNSs) to Malawian women during pregnancy on their plasma selenium concentrations at 36 wk of gestation.MethodsPregnant women (≤20 wk of gestation) were randomly assigned to receive daily either: 1) iron and folic acid (IFA); 2) multiple micronutrients (MMN; 130 µg selenium per capsule); or 3) SQ-LNS (130 µg selenium/20 g). Plasma selenium concentrations were measured by inductively coupled plasma mass spectrometry at baseline and after ≥16 wk of intervention (at 36 wk of gestation) and compared by intervention group.ResultsAt 36 wk of gestation, median (quartile 1, quartile 3) plasma selenium concentrations (micromoles per liter) were 0.96 (0.73, 1.23), 0.94 (0.78, 1.18), and 1.01 (0.85, 1.28) in the IFA, MMN, and SQ-LNS groups, respectively. Geometric mean (GM) plasma selenium concentration was 5.4% (95% CI: 1.8%, 9.0%) higher in the SQ-LNS group than in the MMN group and tended to be higher than in the IFA group (+4.2%; 95% CI: 1.0%, 7.8%). The prevalence of adjusted plasma selenium concentrations <1 µmol/L was 55.1%, 57.8%, and 47.3% in the IFA, MMN, and SQ-LNS groups, respectively; it was lower in the SQ-LNS group than in the MMN group, OR = 0.44 (95% CI: 0.24, 0.83), and tended to be lower than in the IFA group, OR = 0.54 (95% CI: 0.29, 1.03). There was a significant interaction between baseline plasma selenium concentration and intervention group (P = 0.003). In the lowest tertile of baseline selenium concentrations, GM plasma selenium concentration was higher, and the prevalence of low values was lower in the SQ-LNS group compared with the MMN and IFA groups at 36 wk of gestation (P ≤ 0.007).ConclusionsProvision of SQ-LNS containing selenium to pregnant women can be an effective strategy for improving their selenium status.This trial was registered at clinicaltrials.gov (identifier: NCT01239693).

Project description:Abstract Objectives We aimed to assess the effectiveness of nutritional supplementation during the first 1000-days on reduction in the prevalence of stunting in children at 24 months of age. Methods In this cluster randomised controlled trial, we enrolled women during their pregnancy from two rural districts of Sindh, Pakistan. A cluster was one union council with a population of ∼25,000 residents. Out of 29 clusters, we randomly allocated 6 clusters to intervention and 6 to control group. Pregnant women received a monthly ration of 5 kg (i.e., 165 grams/day) of wheat soya blend plus (WSB+) during pregnancy and the first six months of their lactation period, and their children received lipid-based nutrient supplement - medium-quantity (LNS-MQ) between 6–23 months of age. The primary outcome was reduction in the prevalence of stunting in children at 24 months of age. Analysis was by intention to treat. The trial is registered in ClinicalTrial.gov, number NCT02422953. Results 2030 pregnant women (1017 in the intervention group and 1013 in the control group) were enrolled between August 30, 2014 and May 25, 2016. Monthly follow-ups were conducted between October 1, 2014 and October 25, 2018. At 24 months of age, data from 702 (78%) of 902 livebirths in the intervention group and 658 (76%) of 860 livebirths in the control group were available. There was a significant difference in mean length (49.4 cm vs 48.9 cm, p = 0.027), weight (3.1 kg vs 3.0 kg, p = 0.013), length for age z-scores (−1.2 vs −1.5, p = 0.004) and weight for age z-scores (−1.2 vs −1.5, p = 0.015) among infants in the intervention compared to control group. At 24 months of age, a significant difference in the prevalence of stunting (absolute difference, −10.2%, 95% CI −18.2 to −2.3, p = 0.017) and underweight (absolute difference, −13.7%, 95% CI −20.3 to −7.0, p = 0.001) were observed in the intervention as compared to the control group. The difference in the prevalence of wasting was not significant between the intervention and control groups (absolute difference, −6.9%, 95% CI −14.1 to −0.3, p = 0.057). Conclusions Provision of WSB + and LNS-MQ during the first 1000-days of life improved child linear growth and reduced stunting in children at 24 months of age. This study can be scaled-up in the similar settings for reduction in the prevalence of stunting in children under-two years of age. Funding Sources World Food Programme.

Dataset Information

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

Publications

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

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