Prevention of vitamin A deficiency by supplementation alongside routine vaccinations: a randomised controlled trial in Tanzanian infants
Completed
- Conditions
- Vitamin A deficiencyNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN83465214
- Lead Sponsor
- World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 770
Inclusion Criteria
1. Mothers normally resident in the study area
2. Informed consent obtained from the mother
Exclusion Criteria
1. Mothers unable to give informed consent
2. Mothers considered to be at high risk of adverse outcome in puerperal period
3. Multiple deliveries
4. Severe adverse reaction to vitamin A supplementation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Prevalence of Vitamin A Deficiency (VAD) (any: less than 20 mg/dL and severe: less than 10 mg/dL) at 6 months of age<br>2. Incidence of each of the following: <br>2.1. Bulging fontanelle<br>2.2. Temperature greater than 37.5°C<br>2.3. Vomiting<br>2.4. Diarrhoea <br>2.5. Inability to suck/feed during the two days following each vitamin A supplementation
- Secondary Outcome Measures
Name Time Method 1. Mean serum retinol concentration at 6 months of age <br>2. Prevalence of VAD (any and severe) at 9 months of age <br>3. Mean retinol concentration at 9 months of age