NCT03072277

Maternal DHA Supplementation and Offspring Neurodevelopment in India (DHANI-2)

Maternal Docosa-Hexaenoic Acid (DHA) Supplementation and Offspring Neurodevelopment in India (DHANI-2)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 957 (actual)
• Sponsor: Public Health Foundation of India · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

DHANI-2 is an extension to DHANI (NCT01580345) which proposes to extend maternal supplementation (DHA or Placebo) from \<20 weeks of gestational age through 6 months postpartum and infant follow-up through 12 months. Leveraging the Randomized Controlled Trial (RCT) design, DHANI-2 aims to assess the role of maternal DHA supplementation on infant neurodevelopment and body growth. It also intends to enhance the mechanistic understanding by the addition of repeated biochemical measures from mother-child dyads.

Detailed description

A double-blinded, randomized, placebo controlled trial would be conducted among pregnant women in India to test the effectiveness of supplementing pregnant Indian women with 400 mg/d algal DHA compared to placebo from mid-pregnancy through delivery. Eligible participants would be randomized to receive either 400 mg of DHA or a placebo baseline measures would be taken before the enrollment of the participant in the study. The mother-child dyads would be followed through infant age 1 year and anthropometric measurements and biochemical investigations would be used to assess the effect of maternal DHA supplementation on infant neurodevelopment at ages 6- and 12-months using validated the Development Assessment Scale for Indian Infants (DASII).

Conditions

• Pregnancy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Docosa Hexaenoic Acid (DHA)	400 mg/day of Docosa-hexaenoic Acid (algal DHA) will given to the pregnant women (in the active group) from ≤20 weeks of gestation through 6 months postpartum.
DIETARY_SUPPLEMENT	Placebo	400 mg/day of placebo (corn/soy oil) will be given to the pregnant women from ≤20 weeks of gestation through 6 months postpartum.

Timeline

• Start date: 2015-12-01
• Primary completion: 2019-04-01
• Completion: 2020-12-01
• First posted: 2017-03-07
• Last updated: 2021-03-18

Locations

1 site across 1 country: India