Effect of Maternal Docosahexaenoic Acid (DHA) Supplementation on Offspring Neurodevelopment at 12 Months in India: A Randomized Controlled Trial

• Type of Material: Article
• Authors: Shweta Khandelwal, Public Health Foundation of India; Dimple Kondal, Emory University; Monica Chaudhry, Public Health Foundation of India; Kamal Patil, JNMC KLE University Campus; Mallaiah Kenchaveeraiah Swamy, JNMC KLE University Campus; Deepa Metgud, JNMC KLE University Campus; Sandesh Jogalekar, JNMC KLE University Campus; Mahesh Kamate, JNMC KLE University Campus; Gauri Divan, Sangath Goa; Ruby Gupta, Public Health Foundation of India; Dorairaj Prabhakaran, Emory University; Nikhil Tandon, All India Institute of Medical Sciences; Usha Ramakrishnan, Emory University; Aryeh Stein, Emory University
• Language: English
• Date: 2020-10-01
• Publisher: MDPI
• Publication Version: Final Published Version
• Copyright Statement: © 2020 by the authors.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.3390/nu12103041
• Title of Journal or Parent Work: NUTRIENTS
• Volume: 12
• Issue: 10
• Start Page: 1
• End Page: 15
• Grant/Funding Information: This trial is funded by DBT/Wellcome Trust India Alliance (India Alliance) (December 2015–December 2020) via Grant number IA/CPHE/14/1/501498. The Young Scientist Award by DST SERB India (2013–16) via grant number SR/FT/LS-156/2011 helped us establish a part of the DHANI trial cohort. The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Trial Registration—ClinicalTrials.gov Identifier NCT03072277; Ctri.nic.in Identifier CTRI/2017/08/009296.
• Keywords: docosahexaenoic acid (DHA); Nutrition & Dietetics; Science & Technology; PREGNANCY; CHAIN PUFA SUPPLEMENTATION; FOLLOW-UP; pregnancy; Life Sciences & Biomedicine; maternal supplementation; POLYUNSATURATED FATTY-ACIDS; CHILD-DEVELOPMENT; LACTATION; lactation; randomized controlled trial (RCT); BRAIN-DEVELOPMENT; India; VISUAL-ACUITY; neurodevelopment; DEVELOPING-COUNTRIES; YOUNG-CHILDREN
• Research Categories: Health Sciences, Nutrition; Biology, Neuroscience; Health Sciences, Human Development; Health Sciences, Public Health

Abstract

Intake of dietary docosahexaenoic acid (DHA 22:6n-3) is very low among Indian pregnant women. Maternal supplementation during pregnancy and lactation may benefit offspring neurodevelopment. We conducted a double-blind, randomized, placebo-controlled trial to test the effectiveness of supplementing pregnant Indian women (singleton gestation) from ≤20 weeks through 6 months postpartum with 400 mg/d algal DHA compared to placebo on neurodevelopment of their offspring at 12 months. Of 3379 women screened, 1131 were found eligible; 957 were randomized. The primary outcome was infant neurodevelopment at 12 months, assessed using the Development Assessment Scale for Indian Infants (DASII). Both groups were well balanced on sociodemographic variables at baseline. More than 72% of women took >90% of their assigned treatment. Twenty-five serious adverse events (SAEs), none related to the intervention, (DHA group = 16; placebo = 9) were noted. Of 902 live births, 878 were followed up to 12 months; the DASII was administered to 863 infants. At 12 months, the mean development quotient (DQ) scores in the DHA and placebo groups were not statistically significant (96.6 ± 12.2 vs. 97.1 ± 13.0, p = 0.60). Supplementing mothers through pregnancy and lactation with 400 mg/d DHA did not impact offspring neurodevelopment at 12 months of age in this setting.