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
| ISRCTN | ISRCTN49285450 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49285450 |
| Protocol serial number | SCC 1126v2 |
| Sponsor | Medical Research Council (MRC) (UK) - International Nutrition Group |
| Funder | Medical Research Council - International Nutrition Group Core Funding |
- Submission date
- 24/08/2009
- Registration date
- 12/11/2009
- Last edited
- 31/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sophie Moore
Scientific
Scientific
MRC Keneba
MRC Laboratories
Fajara
Banjul
PO Box 273
Gambia
| smoore@mrc.gm |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Three-way randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised trial to investigate the effects of pre-natal and infancy nutritional supplementation on infant immune development |
| Study acronym | ENID |
| Study objectives | Early life immunocompetence can be enhanced by a 'life-course' approach to achieve nutritional repletion in late gestation and infancy. |
| Ethics approval(s) | The Gambia Government/MRC The Gambia Joint Ethics Committee, 20/08/2008, ref: SCC 1126v2 |
| Health condition(s) or problem(s) studied | Optimisation of nutritional status for immune development |
| Intervention | Four pregnancy interventions, to be given daily from 12 weeks gestation until delivery: 1. FeFol: Iron-folate, 60 mg iron 400 µg folate, representing the usual standard of care during pregnancy, as per Gambian Government guidelines (control group). 2. MMN: Multiple micronutrients. A combination of 15 micronutrients, specifically designed for use during pregnancy, and as formulated by UNICEF. A single tablet provides the Recommended Dietary Allowance (RDA) for each micronutrient, but we will supplement women in this arm of the trial with two daily MMN tablets. 3. PE + FeFol: Protein-energy and iron-folate. A food-based supplement developed by Valid International, providing a comparable level of iron and folate to the FeFol only arm, but with the addition of energy, protein and lipids. 4. PE + MMN: Protein-energy and multiple micronutrients. A micronutrient fortified food-based supplement also developed by Valid International, and providing comparable levels of micronutrients to the MMN arm (including FeFol), in addition to the energy and protein and lipid content. From 6 months of age, infants will further be randomised to receive a nutrient enriched weaning food fortificant or placebo, and for a period of 6 months. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Thymic index at 1, 8, 24 and 52 weeks of age |
| Key secondary outcome measure(s) |
Cellular markers of immunity in a randomly selected sub-cohort of infants, stratified by treatment group. The secondary outcome measurements will be assessed when the infants are 12, 24 and 52 weeks of age. |
| Completion date | 30/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 800 |
| Total final enrolment | 875 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2009 |
| Date of final enrolment | 30/09/2013 |
Locations
Countries of recruitment
- Gambia
Study participating centre
MRC Keneba
Banjul
PO Box 273
Gambia
PO Box 273
Gambia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2014 | Yes | No | |
| Results article | results | 01/02/2017 | Yes | No | |
| Results article | results | 01/06/2017 | Yes | No | |
| Results article | results | 01/06/2017 | Yes | No | |
| Results article | results | 18/02/2019 | Yes | No | |
| Results article | results | 06/08/2019 | 10/01/2020 | Yes | No |
| Results article | 01/07/2021 | 31/03/2021 | Yes | No | |
| Protocol article | protocol | 11/10/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
31/03/2021: Publication reference added.
10/01/2020: Publication reference and total final enrolment number added.
19/02/2019: Publication reference added.
12/05/2017: Publication reference added.
21/04/2017: Publication reference added.
29/12/2016: Publication reference added.
