Maternal Omega-3 fatty acid supplementation and offspring neurodevelopment in India

Phase 3

Completed

• Registration Number: CTRI/2017/08/009296
• Lead Sponsor: The Wellcome Trust DBT India Alliance

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-08-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 957

Inclusion Criteria

1. 18-35 y old pregnant women (singleton) at <20 weeks of gestation (calculated from the last menstrual period or by ultrasound in 1st trimester as suggested by study physician/team).

2. Willing to participate in the study and provide all measurements for her and the offspring including anthropometry, dietary assessment and questionnaires plus the biochemical parameters (blood, breast milk)

3. Witnessed informed consent signed by mother.

Exclusion Criteria

1. Women allergic (if aware) to any of the test products.

2. Women with any known history of bleeding tendency or thrombosis (if aware).

3. Women with high-risk pregnancies â??

- any bleeding episode in the current pregnancy;

- hypertension;

- diagnosed heart disease;

- cancer;

- stroke;

- diabetes

4. Women consuming omega-3 supplements or having used these in 3 months preceding the intervention period.

5. 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified