Effect of DHA Supplementation During Pregnancy on Newborn Outcomes & Offspring Neurodevelopment in India (DHANI-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Centre for Chronic Disease Control, India
Sponsor:
Collaborators:
Department of Science and Technology, Government of India
Jawaharlal Nehru Medical College
Public Health Foundation of India
India Alliance
Information provided by (Responsible Party):
Dr. Shweta Khandelwal, Public Health Foundation of India
ClinicalTrials.gov Identifier:
NCT01580345
First received: April 18, 2012
Last updated: May 16, 2016
Last verified: May 2016
  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 (DHANI) & Maternal Docosahexaenoic Acid (DHA) Supplementation and Offspring Neurodevelopment in India (DHANI-2)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Birth Weight & Gestational Age [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Birth weight & gestational age are the primary measures of this study which to be obtained from new born at the time of delivery.


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: January 2016
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2020 (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 +91-124-4722900 ext 4450 shweta.khandelwal@phfi.org
Contact: Ramkrisna Bhunjawa, MSc +91-124-4722900 ext 4271 ram.bhunjawa@ext.phfi.org

Locations
India
KLEUs Jawaharlal Nehru Medical College- Prabhakar Kore Charitable Hospital Recruiting
Belgaum, Karnataka, India, 590010
Contact: B S Kodkany, MD    +91-831-2473777 ext 1074    drkodkany@jnmc.edu   
Contact: Ramkrisna Bhunjawa, MSc    +91-124-4722900 ext 4271    ram.bhunjawa@ext.phfi.org   
Principal Investigator: B S Kodkany, MD         
Sponsors and Collaborators
Centre for Chronic Disease Control, India
Department of Science and Technology, Government of India
Jawaharlal Nehru Medical College
Public Health Foundation of India
India Alliance
Investigators
Principal Investigator: Shweta Khandelwal, PhD Public Heath Foundation of India & Centre for Chronic Disease Control
  More Information

Responsible Party: Dr. Shweta Khandelwal, Associate Professor & Senior Public Health Nutritionist, Public Health Foundation of India
ClinicalTrials.gov Identifier: NCT01580345     History of Changes
Other Study ID Numbers: SERC/LS-451/2011 
Study First Received: April 18, 2012
Last Updated: May 16, 2016
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 May 26, 2016