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
Secondary identifying numbers	SCC 1126v2

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

Not provided at time of registration

Contact information

Dr Sophie Moore
Scientific

MRC Keneba
MRC Laboratories
Fajara
Banjul
PO Box 273
Gambia

Email	smoore@mrc.gm

Study information

Study design	Three-way randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient 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 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
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

Eligibility

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 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 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

Medical Research Council (MRC) (UK) - International Nutrition Group
Research council

MRC London Centre
Stephenson House
158 - 160 North Gower Street
London
NW1 2ND
United Kingdom

Phone	+44 (0)20 7636 8636
Email	andrew.prentice@lshtm.ac.uk
Website	http://www.mrc.ac.uk
"ROR"	https://ror.org/050pqs331

Funders

Funder type

Research council

Medical Research Council - International Nutrition Group Core Funding
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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

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.