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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Dietary supplement: Docosa-hexaenoic acid (DHA); Dietary supplement: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Belgaum, Karnataka, India, 590010
      • KLEUs Jawaharlal Nehru Medical College- Prabhakar Kore Charitable Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Docosa-hexaenoic Acid (DHA)	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.; Other Names: DHA; Omega 3 fatty acid
Placebo Comparator: Placebo; Corn-Soy Oil	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.; Other Names: Corn/Soy oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newborn anthropometry.	Measures for new born anthropometry would include birth weight, length and head circumference	At delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational age		At delivery
New born APGAR Score	APGAR : Appearance, Pulse, Grimace, Activity, Respiration scores	At delivery (1 min and 5 mins)
Unfavorable pregnancy outcomes	Still births, low birth weight babies and preterm babies	At delivery

Collaborators and Investigators

• Sponsor: Centre for Chronic Disease Control, India
• Collaborators: Jawaharlal Nehru Medical College; Department of Science and Technology, Government of India
• Investigators: Principal Investigator: Shweta Khandelwal, PhD, Centre for Chronic Disease Control (CCDC)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): December 6, 2016
• Study Completion (Actual): December 9, 2016

Study Registration Dates

• First Submitted: April 18, 2012
• First Submitted That Met QC Criteria: April 18, 2012
• First Posted (Estimate): April 19, 2012

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 20, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Supplementation; Pregnancy; Randomized controlled trial; RCT; DHA; India; Omega 3 fatty acid; Decosa hexaenoic acid; Newborn outcome; Birth size; gestational age
• Other Study ID Numbers: SERC/LS-451/2011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No