Optimisation of vitamin A dosing schedules in infancy
| ISRCTN | ISRCTN98554309 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98554309 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/08/2005
- Registration date
- 10/10/2005
- Last edited
- 27/07/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Andrew Prentice
Scientific
Scientific
MRC International Nutrition Group
London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom
| Phone | +44 (0)20 7958 8140 |
|---|---|
| andrew.prentice@lshtm.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| 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 | 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 study start date | 01/09/2001 |
| Completion date | 01/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- Gambia
- United Kingdom
Study participating centre
MRC International Nutrition Group
London
WC1E 7HT
United Kingdom
WC1E 7HT
United Kingdom
Sponsor information
Medical Research Council (UK)
Research council
Research council
20 Park Crescent
London
W1N 4AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| corporate@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
"ROR" |
https://ror.org/03x94j517 |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
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? |
|---|---|---|---|---|---|
| Results article | Results: | 23/06/2007 | Yes | No |
