Investigating the effects of pre-natal and infancy nutritional supplementation on infant immune development in The Gambia: the Early Nutrition and Immune Development (ENID) trial

Not Applicable

Completed

• Conditions: Optimisation of nutritional status for immune development; Pregnancy and Childbirth

• Registration Number: ISRCTN49285450
• Lead Sponsor: Medical Research Council (MRC) (UK) - International Nutrition Group

Brief Summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23057665 2. 2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24125806 3. 2016 results in https://www.ncbi.nlm.nih.gov/pubmed/28003540 4. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28424258 5. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28490512 6. 2019 results in https://www.ncbi.nlm.nih.gov/pubmed/30773140 7. 2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31386660 (added 10/01/2020) 8. 2021 results in https://pubmed.ncbi.nlm.nih.gov/33784438/ (added 31/03/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-12
• Study Completion: 2013-09-30
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 875

Inclusion Criteria

Amended as of 04/10/2010:
Women (aged 18 to 45 years) resident in Kiang West Region, The Gambia, with pregnancy confirmed by urine test and ultrasound examination and with gestational age approximately 10 - 20 weeks.

Initial information at time of registration:
Women (aged 18 to 45 years) resident in Kiang West Region, The Gambia, with pregnancy confirmed by urine test and ultrasound examination and with gestational age approximately 12 weeks

Exclusion Criteria

Amended as of 04/10/2010:
1. Currently enrolled in another MRC study or current pregnancy (beyond 20 weeks on ultrasound assessment)
2. Severe anaemia (haemoglobin [Hb] less than 7 g/dL)
3. Reported onset of menopause

Initial information at time of registration:
1. Currently enrolled in another MRC study or current pregnancy (beyond 12 weeks on ultrasound assessment)
2. Severe anaemia (haemoglobin [Hb] less than 7 g/dL)
3. Reported onset of menopause

Study & Design

• Study Type: Interventional
• Study Design: Not specified