Impact Of Food Supplements On Early Child Development In Children With Moderate Acute Malnutrition: A Randomised 2 X 2 X 3 Factorial Trial In Burkina Faso

BackgroundLipid-based nutrient supplements (LNS) and corn-soy blends (CSBs) with varying soy and milk content are used in treatment of moderate acute malnutrition (MAM). We assessed the impact of these supplements on child development.Methods and findingsWe conducted a randomised 2 x 2 x 3 factorial trial to assess the effectiveness of 12 weeks' supplementation with LNS or CSB, with either soy isolate or dehulled soy, and either 0%, 20%, or 50% of protein from milk, on child development among 6-23-month-old children with MAM. Recruitment took place at 5 health centres in Province du Passore, Burkina Faso between September 2013 and August 2014. The study was fully blinded with respect to soy quality and milk content, while study participants were not blinded with respect to matrix. This analysis presents secondary trial outcomes: Gross motor, fine motor, and language development were assessed using the Malawi Development Assessment Tool (MDAT). Of 1,609 children enrolled, 54.7% were girls, and median age was 11.3 months (interquartile range [IQR] 8.2-16.0). Twelve weeks follow-up was completed by 1,548 (96.2%), and 24 weeks follow-up was completed by 1,503 (93.4%); follow-up was similar between randomised groups. During the study, 4 children died, and 102 children developed severe acute malnutrition (SAM). There was no difference in adverse events between randomised groups. At 12 weeks, the mean MDAT z-scores in the whole cohort had increased by 0.33 (95% CI: 0.28, 0.37), p < 0.001 for gross motor; 0.26 (0.20, 0.31), p < 0.001 for fine motor; and 0.14 (0.09, 0.20), p < 0.001 for language development. Children had larger improvement in language z-scores if receiving supplements with milk (20%: 0.09 [-0.01, 0.19], p = 0.08 and 50%: 0.11 [0.01, 0.21], p = 0.02), although the difference only reached statistical significance for 50% milk. Post hoc analyses suggested that this effect was specific to boys (interaction p = 0.02). The fine motor z-scores were also improved in children receiving milk, but only when 20% milk was added to CSB (0.18 [0.03, 0.33], p = 0.02). Soy isolate over dehulled soy increased language z-scores by 0.07 (-0.01, 0.15), p = 0.10, although not statistically significant. Post hoc analyses suggested that LNS benefited gross motor development among boys more than did CSB (interaction p = 0.04). Differences between supplement groups did not persist at 24 weeks, but MDAT z-scores continued to increase post-supplementation. The lack of an unsupplemented control group limits us from determining the overall effects of nutritional supplementation for children with MAM.ConclusionsIn this study, we found that child development improved during and after supplementation for treatment of MAM. Milk protein was beneficial for language and fine motor development, while suggested benefits related to soy quality and supplement matrix merit further investigation. Supplement-specific effects were not found post-intervention, but z-scores continued to improve, suggesting a sustained overall effect of supplementation.Author summaryWhy was this study done?Moderate acute malnutrition (MAM) affects more than 33 million children globally with long-term consequences for their development.There has been a call for research on the effects of MAM treatment on functional outcomes, but previous trials have not assessed effects of the treatments on child development.What did the researchers do and find?We conducted a randomised trial of 1,609 children with MAM in Burkina Faso to investigate the effectiveness of supplemental foods, including a comparison of matrix (lipid-based nutrient supplements [LNS] or corn-soy blend [CSB]), soy quality (soy isolate or dehulled soy), and content of milk protein (0%, 20%, or 50% of protein).We assessed child development as gross motor, fine motor, language, and cognitive skills using the Malawi Development Assessment Tool (MDAT).We found that child development improved across intervention groups during the supplementation and continued to improve after the supplementation had ended.Supplements containing milk protein were beneficial for fine motor and language development.Our findings also indicated a benefit of soy isolate over dehulled soy and a benefit of LNS over CSB among boys.What do these findings mean?Previously reported findings from this trial showed that children mainly put on fat-free mass during supplementation. With the data presented here, we show that motor, language, and cognitive development of children also improve during supplementation and that this improvement is sustained post-supplementation. Our results support the use of milk protein in food products, while suggested benefits of soy isolate and LNS merit further investigation.These findings contribute to the needed evidence of supplementation effects on functional outcomes, including child development, and allow better understanding of children's ability to thrive following MAM treatment.