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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01580345
First Posted: April 19, 2012
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Department of Science and Technology, Government of India
Jawaharlal Nehru Medical College
Information provided by (Responsible Party):
Dr. Shweta Khandelwal, Centre for Chronic Disease Control, India
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Docosa-Hexanoic Acid (DHA) Supplements During Pregnancy on Newborn Outcomes in India (DHANI)

Resource links provided by NLM:


Further study details as provided by Dr. Shweta Khandelwal, Centre for Chronic Disease Control, India:

Primary Outcome Measures:
  • Newborn anthropometry. [ Time Frame: At delivery ]
    Measures for new born anthropometry would include birth weight, length and head circumference


Secondary Outcome Measures:
  • Gestational age [ Time Frame: At delivery ]
  • New born APGAR Score [ Time Frame: At delivery (1 min and 5 mins) ]
    APGAR : Appearance, Pulse, Grimace, Activity, Respiration scores

  • Unfavorable pregnancy outcomes [ Time Frame: At delivery ]
    Still births, low birth weight babies and preterm babies


Enrollment: 600
Study Start Date: December 2015
Study Completion Date: December 9, 2016
Primary Completion Date: December 6, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Corn/Soy oil

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01580345


Locations
India
KLEUs Jawaharlal Nehru Medical College- Prabhakar Kore Charitable Hospital
Belgaum, Karnataka, India, 590010
Sponsors and Collaborators
Centre for Chronic Disease Control, India
Department of Science and Technology, Government of India
Jawaharlal Nehru Medical College
Investigators
Principal Investigator: Shweta Khandelwal, PhD Centre for Chronic Disease Control (CCDC)
  More Information

Responsible Party: Dr. Shweta Khandelwal, Senior Public Health Nutritionist, Centre for Chronic Disease Control, India
ClinicalTrials.gov Identifier: NCT01580345     History of Changes
Other Study ID Numbers: SERC/LS-451/2011
First Submitted: April 18, 2012
First Posted: April 19, 2012
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. Shweta Khandelwal, 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