Contact information
Type
Scientific
Primary contact
Prof Andrew Prentice
ORCID ID
Contact details
MRC International Nutrition Group
London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom
+44 (0)20 7958 8140
andrew.prentice@lshtm.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Early high-dose vitamin A supplementation of mothers and infants improves vitamin A status and protects against mucosal infections, growth faltering and illness compared to the standard World Health Organisation (WHO) regimen.
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Vitamin A deficiency
Intervention
Early high dose Vitamin A schedule versus standard WHO schedule.
Intervention type
Supplement
Phase
Not Specified
Drug names
Vitamin A
Primary outcome measures
1. Vitamin A status in mothers and infants
2. Heliobacter pylori infection in infants
3. Nasopharyngeal pneumococcal carriage in mothers and infants
4. Gut permeability in infants assessed by Dual Pugar Permeability Test (DSPT)
Secondary outcome measures
1. Infant growth
2. Infant morbidity
3. Breast milk sodium-potassium ratios
4. Breast-milk oligosaccharides
Overall trial start date
01/09/2001
Overall trial end date
01/10/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Consenting mothers and new born infants in six villages in the West Kiang region of The Gambia.
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
220
Participant exclusion criteria
1. Congenital defects
2. Birthweight under 2200 g
Recruitment start date
01/09/2001
Recruitment end date
01/10/2004
Locations
Countries of recruitment
Gambia
Trial participating centre
MRC International Nutrition Group
London
WC1E 7HT
United Kingdom
Sponsor information
Organisation
Medical Research Council (UK)
Sponsor details
20 Park Crescent
London
W1N 4AL
United Kingdom
+44 (0)20 7636 5422
corporate@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Publication citations
-
Results
Darboe MK, Thurnham DI, Morgan G, Adegbola RA, Secka O, Solon JA, Jackson SJ, Northrop-Clewes C, Fulford TJ, Doherty CP, Prentice AM, Effectiveness of an early supplementation scheme of high-dose vitamin A versus standard WHO protocol in Gambian mothers and infants: a randomised controlled trial., Lancet, 2007, 369, 9579, 2088-2096, doi: 10.1016/S0140-6736(07)60981-7.