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Register:	ISRCTN
Last refreshed on:	13 January 2015
Main ID:	ISRCTN97670178
Date of registration:	24/11/2004
Prospective Registration:	No
Primary sponsor:	World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
Public title:	Prevention of vitamin A deficiency by supplementation alongside routine vaccinations: a randomised controlled trial in Ghana infants
Scientific title:
Date of first enrolment:	01/01/2004
Target sample size:	1400
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN97670178
Study type:	Interventional
Study design:	Randomised controlled trial (Prevention)
Phase:

Countries of recruitment
Ghana

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Tracey Goodman
Address:	World Health Organization 20, Avenue Appia CH-1211 Geneva-27 Switzerland
Telephone:
Email:	goodmant@who.int
Affiliation:

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Vitamin A Deficiency
Nutritional, Metabolic, Endocrine
Nutritional deficiency

Intervention(s)

1st Group:
1. Mothers 200,000 IU Vitamin A shortly after delivery
2. Infants: 25,000 IU Vitamin A with each Diphtheria, Pertussis, Tetanus (DPT) vaccine 1, 2 and 3

2nd Group:
1. Mothers 200,000 IU Vitamin A at infant's Bacillus Calmette-Guerin (BCG) vaccine and another 200,000 IU Vitamin A at infant's 1st DPT
2. Infants: 50,000 IU Vitamin A with each DPT 1, 2 and 3

Primary Outcome(s)

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

Secondary Outcome(s)

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
2. mRDR testing of infants at 9 months of age

Secondary ID(s)

N/A

Source(s) of Monetary Support

World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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