Optimisation of vitamin A dosing schedules in infancy

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Andrew Prentice
Scientific

MRC International Nutrition Group
London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom

Phone	+44 (0)20 7958 8140
Email	andrew.prentice@lshtm.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Vitamin A deficiency
Intervention	Early high dose Vitamin A schedule versus standard WHO schedule.
Intervention type	Supplement
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	1. Infant growth 2. Infant morbidity 3. Breast milk sodium-potassium ratios 4. Breast-milk oligosaccharides
Completion date	01/10/2004

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	220
Key inclusion criteria	Consenting mothers and new born infants in six villages in the West Kiang region of The Gambia.
Key exclusion criteria	1. Congenital defects 2. Birthweight under 2200 g
Date of first enrolment	01/09/2001
Date of final enrolment	01/10/2004

MRC International Nutrition Group

London
WC1E 7HT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results:	23/06/2007		Yes	No