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

Pregnancy Clinical Trial

— DHANI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580345
• Other study ID #: SERC/LS-451/2011
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2012
• Last updated: February 20, 2017
• Start date: December 2015
• Est. completion date: December 9, 2016

Study information

• Verified date: February 2017
• Source: Centre for Chronic Disease Control, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 9, 2016
• Est. primary completion date: December 6, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pregnancy

Intervention

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 delivery.
• Placebo
400 mg/day of placebo (corn/soy oil) will be given to the pregnant women from =20 weeks of gestation through delivery.

Locations

Country	Name	City	State
India	KLEUs Jawaharlal Nehru Medical College- Prabhakar Kore Charitable Hospital	Belgaum	Karnataka

Sponsors (3)

Lead Sponsor	Collaborator
Centre for Chronic Disease Control, India	Department of Science and Technology, Government of India, Jawaharlal Nehru Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Newborn anthropometry.	Measures for new born anthropometry would include birth weight, length and head circumference	At delivery
Secondary	Gestational age		At delivery
Secondary	New born APGAR Score	APGAR : Appearance, Pulse, Grimace, Activity, Respiration scores	At delivery (1 min and 5 mins)
Secondary	Unfavorable pregnancy outcomes	Still births, low birth weight babies and preterm babies	At delivery