Effect of Docosa-Hexanoic Acid (DHA) Supplements During Pregnancy on Newborn Outcomes in India.

NCT ID: NCT01580345

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-12-09

Brief Summary

The 'DHANI randomized controlled trial" seeks to examine the effects of prenatal DHA supplementation on newborn anthropometry where in healthy pregnant will be assigned to receive either 400 mg of DHA or a placebo daily from ≤20 weeks gestation through delivery.

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. This study would assess the effect of maternal DHA supplementation on:

1. New born anthropometry (birth weight, length and head circumference)

2. New born APGAR score

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Docosa-hexaenoic Acid (DHA)

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 delivery.

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 delivery.

Interventions

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 delivery.

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 delivery.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

DHA; Omega 3 fatty acid; Corn/Soy oil

Eligibility Criteria

Inclusion Criteria

• 18 to 35 year old pregnant women (singleton) at <=20 weeks of gestation (calculated from the LMP by study physician).
• Willing to participate in the study and perform all measurements for self, husband and the offspring including anthropometry, dietary assessment, questionnaires and biological samples (blood and breast milk).
• Willing to provide signed and dated informed consent.

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

Sponsors

Department of Science and Technology, Government of India

UNKNOWN

Sponsor Role: collaborator

Jawaharlal Nehru Medical College

OTHER

Sponsor Role: collaborator

Centre for Chronic Disease Control, India

OTHER

Sponsor Role: lead

Responsible Party

Dr. Shweta Khandelwal

Senior Public Health Nutritionist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shweta Khandelwal, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Chronic Disease Control (CCDC)

Locations

KLEUs Jawaharlal Nehru Medical College- Prabhakar Kore Charitable Hospital

Belagavi, Karnataka, India

Countries

India

References

Khandelwal S, Swamy MK, Patil K, Kondal D, Chaudhry M, Gupta R, Divan G, Kamate M, Ramakrishnan L, Bellad MB, Gan A, Kodkany BS, Martorell R, Srinath Reddy K, Prabhakaran D, Ramakrishnan U, Tandon N, Stein AD. The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol. BMC Pediatr. 2018 Aug 4;18(1):261. doi: 10.1186/s12887-018-1225-5.

Reference Type: DERIVED

PMID: 30077178 (View on PubMed)

Other Identifiers

SERC/LS-451/2011

Identifier Type: -

Identifier Source: org_study_id