NCT03072277

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
957

participants targeted

Target at P50-P75 for phase_3 pregnancy

Timeline
Completed

Started Dec 2015

Longer than P75 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

Study Start

First participant enrolled

December 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

3.3 years

First QC Date

February 23, 2017

Last Update Submit

March 16, 2021

Conditions

Pregnancy

Keywords

DHADocosa Hexaenoic AcidOmega 3 fatty acidBirth OutcomeBirth SizeGestational AgeDASIIPrenatal and Postnatal SupplementationRandomized Controlled TrialNeurodevelopmentPregnancyLactation

Outcome Measures

Primary Outcomes (1)

  • Infant neurodevelopment as measured by his/her Development quotient scores (DQS) at 12 months of age

    The development quotient (DQ) among infants at 12 months of age assessed using the standardized Development Assessment Scale for Indian Infants (DASII). DASII is the Indian modification (done in 1970 and 1977) of the Bayley Scale of Infant Development (BSID) using Indian norms for 67 motor and 163 mental items of the BSID. DASII provides a measure of DQ among Indian infants below 30 months of age. DQ is defined as the ratio of functional to chronological age. Third, 50th and 97th percentile norms are given. A higher score indicates a better outcome. The maximum DQ score is 100; ≥85 is normal; 71-84 is mild to moderate delay and developmental delay is defined as DQ ≤70 (≤2SD). Median reliability index for motor and mental scales based on correlation between consecutive months is noted to be 0.88 for motor scales and 0.91 for mental scales.

    12 months (± 4 weeks)

Secondary Outcomes (15)

  • Mean difference in infant developmental quotient (DQ) at 6 month

    6 months (± 4 weeks)

  • Mean difference in infant motor score at 6 month

    6 (± 4 weeks)

  • Mean difference in infant mental score at 6 month

    6 months (± 4 weeks)

  • Difference in numbers / proportions of infants with developmental delay

    6 months (± 4 weeks) and 12 (± 4 weeks) months

  • Mean difference in infant weight (in grams) at birth

    At delivery

  • +10 more secondary outcomes

Study Arms (2)

Docosa Hexaenoic Acid (DHA)

ACTIVE COMPARATOR

Omega 3 Fatty Acid

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 6 months postpartum.

Also known as: 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 6 months postpartum.

Also known as: Corn/Soy oil
Placebo

Eligibility Criteria

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

You may qualify if:

  • Willing, healthy singleton gestation of ≤ 20 weeks (scan report must)
  • 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.

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 (3)

  • 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: 30077178BACKGROUND

  • 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.

    PMID: 33023067RESULT

  • 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.

    PMID: 33668849RESULT

Related Links

MeSH Terms

Conditions

Breast Feeding

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized, double blinded, parallel arm hospital based trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2017

First Posted

March 7, 2017

Study Start

December 1, 2015

Primary Completion

April 1, 2019

Study Completion

December 1, 2020

Last Updated

March 18, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)