Condition category
Pregnancy and Childbirth
Date applied
24/08/2009
Date assigned
12/11/2009
Last edited
03/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sophie Moore

ORCID ID

Contact details

MRC Keneba
MRC Laboratories
Fajara
Banjul
PO Box 273
Gambia
smoore@mrc.gm

Additional identifiers

EudraCT 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

The Gambia Government/MRC The Gambia Joint Ethics Committee Approval received on 20th August 2008 (ref: SCC 1126v2)

Study design

Three-way randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/10/2009

Overall trial end date

30/09/2013

Reason abandoned

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

Patient

Age group

Adult

Gender

Female

Target number of participants

800 mother-infant pairs

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

Trial 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
andrew.prentice@lshtm.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) - International Nutrition Group Core Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23057665
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24125806

Publication citations

  1. Protocol

    Moore SE, Fulford AJ, Darboe MK, Jobarteh ML, Jarjou LM, Prentice AM, A randomized trial to investigate the effects of pre-natal and infant nutritional supplementation on infant immune development in rural Gambia: the ENID trial: Early Nutrition and Immune Development., BMC Pregnancy Childbirth, 2012, 12, 107, doi: 10.1186/1471-2393-12-107.

  2. Results

    Jobarteh ML, Moore SE, Kennedy C, Gambling L, McArdle HJ, The effect of delay in collection and processing on RNA integrity in human placenta: experiences from rural Africa., Placenta, 2014, 35, 1, 72-74, doi: 10.1016/j.placenta.2013.08.016.

Additional files

Editorial Notes