Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Docosa-hexaenoic Acid (DHA) Supplementation During Pregnancy on Newborn Outcome in India (DHANI_RCT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Centre for Chronic Disease Control, India
Sponsor:
Collaborators:
Department of Science and Technology
Jawaharlal Nehru Medical College
Information provided by (Responsible Party):
Dr. Shweta Khandelwal, Centre for Chronic Disease Control, India
ClinicalTrials.gov Identifier:
NCT01580345
First received: April 18, 2012
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

Low birth weight and preterm birth-the leading causes of neonatal morbidity and mortality will be prevented by Docosa hexaenoic acid(DHA-omega 3 fatty acid)during pregnancy (from <=20 weeks of gestation through delivery)


Condition Intervention Phase
Pregnancy
Dietary Supplement: Docosa-hexaenoic acid (DHA)
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Effect of Docosa-hexaenoic Acid (DHA) Supplementation During Pregnancy on Newborn Outcomes in India - the DHANI Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Centre for Chronic Disease Control, India:

Primary Outcome Measures:
  • Birth Weight [ Time Frame: At delivery ] [ Designated as safety issue: No ]
  • Gestational Age [ Time Frame: At delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Head circumference of the baby [ Time Frame: At delivery ] [ Designated as safety issue: No ]
  • Crown-heel length [ Time Frame: At delivery ] [ Designated as safety issue: No ]
  • APGAR score [ Time Frame: At delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: December 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Docosa-hexaenoic Acid (DHA)
Dietary Supplement : DHA 400 mg/d of docosahexaenoic acid (DHA) will be given to the pregnant women from <=20 weeks of gestation until delivery.
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 until delivery.
Other Names:
  • DHA
  • Omega 3 fatty acid
Placebo Comparator: Corn/Soy oil
400 mg of placebo (corn/soy oil) will be given to the pregnant women from <=20 weeks of gestation until delivery.
Dietary Supplement: Placebo
400 mg of placebo (corn/soy oil) will be given to the pregnant women from <=20 weeks of gestation until delivery.
Other Name: Corn/Soy oil

Detailed Description:

Birth weight is a key indicator of the health trajectory of a child. In addition to being an intrinsic endpoint, low birth weight (LBW) is associated with increased risk of numerous adverse health outcomes in childhood and adulthood. One third of Indian children are born with low birth weight (NFHS-3, 2005-6). Mothers in deprived socio-economic conditions frequently have inadequate nutrition and consequently deliver LBW infants.

Dietary recommendations for pregnant women emphasize protein, energy, vitamin, and mineral adequacy, but recent attention is also being received by dietary lipids, especially essential fatty acids (EFAs). In particular, the n-3 fatty acid, docosahexaenoic acid (DHA), synthesized from alpha-linolenic acid (ALA) and found preformed in oil-rich fish, breast-milk, and algae, is essential for membrane function and plays a key role in the development of the foetal brain and retina. The main dietary source of DHA is oily fish and unsupplemented vegetarian diets contain little and vegan diets contain virtually no DHA. Studies also indicate that Indian adults have been particularly omega-3 deficient. Mounting evidence and current interest points towards supplementation of novel nutrients- omega-3 fatty acids esp DHA during pregnancy to improve birth outcome- over and above the standard of care. In view of the described inconclusive evidence of improved birth outcome by DHA, we propose a supplementation RCT with either DHA or placebo in Indian pregnant women. Our project will provide evidence for broad-based improvements to two quintessential global public health problems- preterm and LBW deliveries. This study will be a collaborative effort between Centre for Chronic Disease Control (CCDC) and KLEUs Jawaharlal Nehru Medical College(JNMC, Belgaum, Karnataka.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18- ≤35 y 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 including anthropometry, dietary assessment and questionnaires.
  • Informed consent signed by subject.

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580345

Contacts
Contact: Shweta Khandelwal, PhD 91-0124-4781400 shweta@ccdcindia.org

Locations
India
KLEUs Jawaharlal Nehru Medical College- Prabhakar Kore Charitable Hospital Not yet recruiting
Belgaum, Karnataka, India, 590010
Contact: B S Kodkany, MD    +91-831-24094059    drkodkany@jnmc.edu   
Principal Investigator: B S Kodkany, MD         
Sponsors and Collaborators
Centre for Chronic Disease Control, India
Department of Science and Technology
Jawaharlal Nehru Medical College
Investigators
Principal Investigator: Shweta Khandelwal, PhD Centre for Chronic Disease Control
  More Information

No publications provided

Responsible Party: Dr. Shweta Khandelwal, Assistant Professor, Centre for Chronic Disease Control, India
ClinicalTrials.gov Identifier: NCT01580345     History of Changes
Other Study ID Numbers: SERC/LS-451/2011
Study First Received: April 18, 2012
Last Updated: July 24, 2014
Health Authority: India: Institutional Review Board

Keywords provided by Centre for Chronic Disease Control, India:
DHA
Omega 3 fatty acid
Decosa hexaenoic acid
Pregnancy
Newborn outcome
Supplementation
Birth size
gestational age
India
Randomized controlled trial
RCT

ClinicalTrials.gov processed this record on November 27, 2014