Clinical trial NCT01580345: Effect of Docosa-Hexanoic Acid (DHA) Supplements During Pregnancy on Newborn Outcomes in India.
Official title: Effect of Docosa-Hexanoic Acid (DHA) Supplements During Pregnancy on Newborn Outcomes in India (DHANI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pregnancy
Keywords: DHA
Omega 3 fatty acid
Decosa hexaenoic acid
Pregnancy
Newborn outcome
Supplementation
Birth size
gestational age
India
Randomized controlled trial
RCT
Lead sponsor: Centre for Chronic Disease Control, India
Sponsor class: OTHER
Collaborators: name: Department of Science and Technology, Government of India
name: Jawaharlal Nehru Medical College
First posted: 2012-04-19
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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).

Primary outcomes:
measure: Newborn anthropometry.
timeFrame: At delivery
Secondary outcomes:
measure: Gestational age
timeFrame: At delivery
measure: New born APGAR Score
timeFrame: At delivery (1 min and 5 mins)
measure: Unfavorable pregnancy outcomes
timeFrame: At delivery
Other outcomes:
Locations:
city: Belgaum
country: India
facility: KLEUs Jawaharlal Nehru Medical College- Prabhakar Kore Charitable Hospital
state: Karnataka
Study officials:
affiliation: Centre for Chronic Disease Control (CCDC)
name: Shweta Khandelwal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.