NCT01580345

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P50-P75 for phase_3 pregnancy

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_3 pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
3.6 years until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2016

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2016

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

April 18, 2012

Last Update Submit

February 20, 2017

Conditions

Pregnancy

Keywords

DHAOmega 3 fatty acidDecosa hexaenoic acidPregnancyNewborn outcomeSupplementationBirth sizegestational ageIndiaRandomized controlled trialRCT

Outcome Measures

Primary Outcomes (1)

  • Newborn anthropometry.

    Measures for new born anthropometry would include birth weight, length and head circumference

    At delivery

Secondary Outcomes (3)

  • Gestational age

    At delivery

  • New born APGAR Score

    At delivery (1 min and 5 mins)

  • Unfavorable pregnancy outcomes

    At delivery

Study Arms (2)

Docosa-hexaenoic Acid (DHA)

ACTIVE COMPARATOR
Dietary Supplement: Docosa-hexaenoic acid (DHA)

Placebo

PLACEBO COMPARATOR

Corn-Soy Oil

Dietary Supplement: Placebo

Interventions

Docosa-hexaenoic acid (DHA)DIETARY_SUPPLEMENT

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.

Also known as: DHA, Omega 3 fatty acid
Docosa-hexaenoic Acid (DHA)
PlaceboDIETARY_SUPPLEMENT

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

Also known as: Corn/Soy oil
Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KLEUs Jawaharlal Nehru Medical College- Prabhakar Kore Charitable Hospital

Belagavi, Karnataka, 590010, India

Location

Related Publications (1)

  • 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.

    PMID: 30077178DERIVED

MeSH Terms

Interventions

Fatty Acids, Omega-3

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Shweta Khandelwal, PhD

    Centre for Chronic Disease Control (CCDC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Public Health Nutritionist

Study Record Dates

First Submitted

April 18, 2012

First Posted

April 19, 2012

Study Start

December 1, 2015

Primary Completion

December 6, 2016

Study Completion

December 9, 2016

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)