Contact information
Type
Scientific
Contact name
Dr Sophie Moore
ORCID ID
Contact details
MRC Keneba
MRC Laboratories
Fajara
Banjul
PO Box 273
Gambia
-
smoore@mrc.gm
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
SCC 1126v2
Study information
Scientific title
A randomised trial to investigate the effects of pre-natal and infancy nutritional supplementation on infant immune development
Acronym
ENID
Study hypothesis
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
Study design
Three-way randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
1. Thymic index at 1, 8, 24 and 52 weeks of age
2. Antibody response to EPI vaccines (diphtheria, tetanus toxoid, HiB, measles)
Secondary outcome measures
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.
Overall study start date
01/10/2009
Overall study end date
30/09/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Female
Target number of participants
800 mother-infant pairs
Total final enrolment
875
Participant 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
Recruitment start date
01/10/2009
Recruitment end date
30/09/2013
Locations
Countries of recruitment
Gambia
Study participating centre
MRC Keneba
Banjul
PO Box 273
Gambia
Sponsor information
Organisation
Medical Research Council (MRC) (UK) - International Nutrition Group
Sponsor details
MRC London Centre
Stephenson House
158 - 160 North Gower Street
London
NW1 2ND
United Kingdom
+44 (0)20 7636 8636
andrew.prentice@lshtm.ac.uk
Sponsor type
Research council
Website
ROR
Funders
Funder type
Research council
Funder name
Medical Research Council - International Nutrition Group Core Funding
Alternative name(s)
UK Medical Research Council, MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/10/2012 | Yes | No | |
| 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 |