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CompletedNCT01580345DHANIUpdated Feb 23, 2017

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

A Phase 3 interventional study of Docosa-hexaenoic acid (DHA) and Placebo in Pregnancy, sponsored by Centre for Chronic Disease Control, India. Completed at 1 site in India. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Centre for Chronic Disease Control, India · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

Read the 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
02

Conditions studied

  • Pregnancy

Keywords

  • DHA
  • Omega 3 fatty acid
  • Decosa hexaenoic acid
  • Pregnancy
  • Newborn outcome
  • Supplementation
  • Birth size
  • gestational age
  • India
  • Randomized controlled trial
  • RCT
03

In context

Lead sponsor

Centre for Chronic Disease Control, India is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
600 participants (actual)

Study arms

  • Active comparator
    Docosa-hexaenoic Acid (DHA)

    Dietary Supplement: Docosa-hexaenoic acid (DHA)

  • Placebo comparator
    Placebo

    Corn-Soy Oil

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementDocosa-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.

    Also known as: DHA, Omega 3 fatty acid

  • Dietary supplementPlacebo

    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

06

What researchers measure

Primary outcomes

  1. Newborn anthropometry.

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

    Time frame: At delivery

Secondary outcomes

  1. Gestational age

    Time frame: At delivery

  2. New born APGAR Score

    APGAR : Appearance, Pulse, Grimace, Activity, Respiration scores

    Time frame: At delivery (1 min and 5 mins)

  3. Unfavorable pregnancy outcomes

    Still births, low birth weight babies and preterm babies

    Time frame: At delivery

07

Study locations

1 site
  • KLEUs Jawaharlal Nehru Medical College- Prabhakar Kore Charitable Hospital
    Belgaum, Karnataka 590010, India
08

References and documents

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. PubMed 30077178 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2015, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 18, 2012
First posted
Apr 19, 2012
Start
Dec 2015
Primary completionActual
Dec 6, 2016
CompletionActual
Dec 9, 2016
Last update
Feb 23, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01580345
Lead sponsor
Centre for Chronic Disease Control, India
Collaborators
Department of Science and Technology, Government of India, Jawaharlal Nehru Medical College
Responsible party
Dr. Shweta Khandelwal (Senior Public Health Nutritionist, Centre for Chronic Disease Control, India) — Principal investigator
First posted
Apr 19, 2012
Start date
Dec 2015
Primary completion
Dec 6, 2016
Completion
Dec 9, 2016
Last update
Feb 23, 2017

Study contacts

Shweta Khandelwal, PhD
principal investigator · Centre for Chronic Disease Control (CCDC)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Omega-3 fatty acid

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