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

• Published in: PLoS medicine 2020-12, Vol.17 (12), p.e1003442-e1003442
• Main Authors: Olsen, Mette F, Iuel-Brockdorff, Ann-Sophie, Yaméogo, Charles W, Cichon, Bernardette, Fabiansen, Christian, Filteau, Suzanne, Phelan, Kevin, Ouédraogo, Albertine, Michaelsen, Kim F, Gladstone, Melissa, Ashorn, Per, Briend, André, Ritz, Christian, Friis, Henrik, Christensen, Vibeke B
• Format: Article
• Language: English
• Subjects: Acute Disease; Age Factors; Analysis; Biology and Life Sciences; Burkina Faso; Care and treatment; Child Development; Child Language; Children; Children & youth; Cognition & reasoning; Community; Comparative analysis; Dietary Supplements; Distribution; Families & family life; Female; Food; Health facilities; Humanitarianism; Humans; Infant; Infant Nutrition Disorders - diagnosis; Infant Nutrition Disorders - diet therapy; Infant Nutrition Disorders - physiopathology; Infant Nutritional Physiological Phenomena; Male; Malnutrition; Malnutrition - diagnosis; Malnutrition - diet therapy; Malnutrition - physiopathology; Malnutrition in children; Meals; Medicine and Health Sciences; Milk; Milk Proteins - administration & dosage; Motor Skills; Nutrition; Nutritional Status; People and Places; Physiological aspects; Proteins; Social Sciences; Soybean Proteins - administration & dosage; Testing; Time Factors; Treatment Outcome
• ISSN: 1549-1676; 1549-1277; 1549-1676
• DOI: 10.1371/journal.pmed.1003442

Lipid-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. We conducted a randomised 2 × 2 × 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 Passoré, 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 limi