Prevention of vitamin A deficiency by supplementation alongside routine vaccinations: a randomised controlled trial in Ghana infants

Completed

• Conditions: Vitamin A Deficiency; Nutritional, Metabolic, Endocrine; Nutritional deficiency

• Registration Number: ISRCTN97670178
• Lead Sponsor: World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11-24
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1400

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. Serum retinol levels, assessed by carrying out mRDR testing of infants at 6 weeks, 6 months and 9 months<br>2. Modified Retinol Dose Response (mRDR) tests<br>3. Incidence of side effects such as bulging of the anterior fontanel and vomiting<br>4. Incidence of severe morbidity

Secondary Outcome Measures

Name	Time	Method
1. Breast milk retinol concentrations, assessed at 6 weeks, 6 months and 9 months for an assessment of the impact of the different supplementation regimes<br>2. mRDR testing of infants at 9 months of age