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Author Notes:

shweta.khandelwal@phfi.org; Tel.: +91-0-9891111858

S.K. had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. She also takes the final responsibility for the decision to submit for publication. Conceptualization, S.K., D.P., N.T., U.R., and A.D.S.; Data curation, D.K.; Formal analysis, D.K. and R.G.; Funding acquisition, S.K. and D.P.; Investigation, S.K., D.M., and S.J.; Methodology, U.R.; Project administration, S.K., M.C., and K.P.; Resources, K.P., M.K.S., and D.P.; Software, D.K.; Supervision, K.P., M.K.S., M.K., N.T., and A.D.S.; Validation, R.G.; Writing—original draft, S.K.; Writing—review & editing, M.C., G.D., D.P., N.T., U.R., and A.D.S. All authors have read and agreed to the published version of the manuscript.

The authors declare no conflict of interest.


Research Funding:

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.


  • Science & Technology
  • Life Sciences & Biomedicine
  • Nutrition & Dietetics
  • maternal supplementation
  • pregnancy
  • lactation
  • docosahexaenoic acid (DHA)
  • neurodevelopment
  • randomized controlled trial (RCT)
  • India

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

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Journal Title:



Volume 12, Number 10


, Pages 1-15

Type of Work:

Article | Final Publisher PDF


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.

Copyright information:

© 2020 by the authors.

This is an Open Access work distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).
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