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

NCT03072277 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 957

Last updated 2021-03-18

No results posted yet for this study

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.

Conditions

  • Pregnancy

Interventions

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.

Sponsors & Collaborators

  • Jawaharlal Nehru Medical College

    collaborator OTHER

  • India Alliance

    collaborator UNKNOWN

  • Public Health Foundation of India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2019-04-30
Completion
2020-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03072277 on ClinicalTrials.gov