Clinical trial NCT03072277: Maternal DHA Supplementation and Offspring Neurodevelopment in India (DHANI-2)
Official title: Maternal Docosa-Hexaenoic Acid (DHA) Supplementation and Offspring Neurodevelopment in India (DHANI-2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pregnancy
Keywords: DHA
Docosa Hexaenoic Acid
Omega 3 fatty acid
Birth Outcome
Birth Size
Gestational Age
DASII
Prenatal and Postnatal Supplementation
Randomized Controlled Trial
Neurodevelopment
Pregnancy
Lactation
Lead sponsor: Public Health Foundation of India
Sponsor class: OTHER
Collaborators: name: Jawaharlal Nehru Medical College
name: India Alliance
First posted: 2017-03-07
Enrollment: 957
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blinded, parallel arm hospital based trial.
Primary purpose: PREVENTION

Brief summary: DHANI-2 is an extension to DHANI (NCT01580345) which proposes to extend maternal supplementation (DHA or Placebo) from \<20 weeks of gestational age through 6 months postpartum and infant follow-up through 12 months. Leveraging the Randomized Controlled Trial (RCT) design, DHANI-2 aims to assess the role of maternal DHA supplementation on infant neurodevelopment and body growth. It also intends to enhance the mechanistic understanding by the addition of repeated biochemical measures from mother-child dyads.

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. The mother-child dyads would be followed through infant age 1 year and anthropometric measurements and biochemical investigations would be used to assess the effect of maternal DHA supplementation on infant neurodevelopment at ages 6- and 12-months using validated the Development Assessment Scale for Indian Infants (DASII).

Eligibility criteria: Inclusion Criteria:

* Willing, healthy singleton gestation of ≤ 20 weeks (scan report must)
* 18-35 years
* Hb \> 7 g/dL
* Non-fasting glucose as per Diabetes in Pregnancy Study Group of India (DIPSI) criteria (\<140mg/dL)
* No history of chronic diseases (heart disease, diabetes, liver disorders, cancer, epilepsy, HIV, thyroid) or
* High risk pregnancy (short stature\*\*, molar pregnancy++, HBsAg positive, as advised by physicians)

  * \<143 cm ++ A molar pregnancy starts when an egg is fertilized, but instead of a normal, viable pregnancy resulting, the placenta develops into an abnormal mass of cysts.

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: Infant neurodevelopment as measured by his/her Development quotient scores (DQS) at 12 months of age
timeFrame: 12 months (± 4 weeks)
Secondary outcomes:
measure: Mean difference in infant developmental quotient (DQ) at 6 month
timeFrame: 6 months (± 4 weeks)
measure: Mean difference in infant motor score at 6 month
timeFrame: 6 (± 4 weeks)
measure: Mean difference in infant mental score at 6 month
timeFrame: 6 months (± 4 weeks)
measure: Difference in numbers / proportions of infants with developmental delay
timeFrame: 6 months (± 4 weeks) and 12 (± 4 weeks) months
measure: Mean difference in infant weight (in grams) at birth
timeFrame: At delivery
measure: Mean difference in infant (in centimeters) at birth
timeFrame: At delivery
measure: Mean difference in infant head circumference (in centimeters) at birth
timeFrame: At delivery
measure: Mean difference in infant APGAR (Appearance, Pulse, Grimace, Activity, Respiration) score at birth.
timeFrame: At delivery
measure: Mean change in infant weight (in grams) at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group
timeFrame: At delivery, 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks)
measure: Mean change in infant length (in centimeters) at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group
timeFrame: At delivery, 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks)
measure: Mean change in infant head circumference (in centimeters) at birth, 1 month, 6 months and 12 months between the Docosahexaenoic acid (DHA) and placebo group
timeFrame: At delivery, 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks)
measure: Mean difference in proportions of still births between Docosahexaenoic acid (DHA) and placebo groups.
timeFrame: At delivery
measure: Mean difference in proportions of preterm babies between Docosahexaenoic acid (DHA) and placebo groups.
timeFrame: At delivery
measure: Mean difference in proportions of low birth weight babies between Docosahexaenoic acid (DHA) and placebo groups.
timeFrame: At delivery
measure: Difference in infant morbidity patterns between Docosahexaenoic acid (DHA) and placebo groups
timeFrame: 1 month (± 4 weeks), 6 months (± 4 weeks) and, 12 months (± 4 weeks)
Other outcomes:
Locations:
city: Belgaum
country: India
facility: KLEUs Jawaharlal Nehru Medical College -- Prabhakar Kore Charitable Hospital
state: Karnataka
Study officials:
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.
citation: Khandelwal S, Kondal D, Chaudhry M, Patil K, Swamy MK, Metgud D, Jogalekar S, Kamate M, Divan G, Gupta R, Prabhakaran D, Tandon N, Ramakrishnan U, Stein AD. Effect of Maternal Docosahexaenoic Acid (DHA) Supplementation on Offspring Neurodevelopment at 12 Months in India: A Randomized Controlled Trial. Nutrients. 2020 Oct 3;12(10):3041. doi: 10.3390/nu12103041.
citation: Khandelwal S, Kondal D, Chaudhry M, Patil K, Swamy MK, Pujeri G, Mane SB, Kudachi Y, Gupta R, Ramakrishnan U, Stein AD, Prabhakaran D, Tandon N. Prenatal Maternal Docosahexaenoic Acid (DHA) Supplementation and Newborn Anthropometry in India: Findings from DHANI. Nutrients. 2021 Feb 25;13(3):730. doi: 10.3390/nu13030730.