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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

957 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double blinded, parallel arm hospital based trial.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Docosa Hexaenoic Acid (DHA)

Omega 3 Fatty Acid

Group Type ACTIVE_COMPARATOR

Docosa Hexaenoic Acid (DHA)

Intervention Type DIETARY_SUPPLEMENT

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.

Placebo

Corn/Soy Oil

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

400 mg/day of placebo (corn/soy oil) will be given to the pregnant women from ≤20 weeks of gestation through 6 months postpartum.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Omega 3 Fatty Acid Corn/Soy oil

Eligibility Criteria

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Inclusion Criteria

* Willing, healthy singleton gestation of ≤ 20 weeks (scan report must)
* 18-35 years
* Hb \> 7 g/dL
* Non-fasting glucose as per Diabetes in Pregnancy Study Group of India (DIPSI) criteria (\<140mg/dL)
* No history of chronic diseases (heart disease, diabetes, liver disorders, cancer, epilepsy, HIV, thyroid) or
* High risk pregnancy (short stature\*\*, molar pregnancy++, HBsAg positive, as advised by physicians)

* \<143 cm ++ A molar pregnancy starts when an egg is fertilized, but instead of a normal, viable pregnancy resulting, the placenta develops into an abnormal mass of cysts.

Exclusion Criteria

* Women allergic (if aware) to any of the test products.
* Women at high risk for hemorrhagic bleeding, clotting (if aware).
* Women with high-risk pregnancies (history and prevalence of pregnancy complications, including abruptio placentae, preeclampsia, pregnancy-induced hypertension, any serious bleeding episode in the current pregnancy, and/ or physician referral); and/or diagnosed chronic degenerative disease(s) such as diagnosed heart disease, cancer, stroke or diabetes (as omega-3 could raise blood sugar and lower insulin production).
* Women consuming omega-3 supplements or having used these in 3 months preceding the intervention period.
* Reported participation in another biomedical trial 3 months before the start of the study or during the study (not to get the results of the present study contaminated).

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes