Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/08/2005
Date assigned
10/10/2005
Last edited
27/07/2007
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

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

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17586304

Publication citations

  1. 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.

Additional files

Editorial Notes