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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN83465214 |
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Date of registration:
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22/09/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prevention of vitamin A deficiency by supplementation alongside routine vaccinations: a randomised controlled trial in Tanzanian infants
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Scientific title:
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Date of first enrolment:
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01/12/2001 |
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Target sample size:
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770 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN83465214 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Prevention)
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Phase:
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Countries of recruitment
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Tanzania
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Tracey
Goodman |
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Address:
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World Health Organization
20 Avenue Appia
CH-1211
Geneva-27
Switzerland |
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Telephone:
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Email:
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goodmant@who.int |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Vitamin A deficiency
Nutritional, Metabolic, Endocrine
Vitamin A deficiency
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Intervention(s)
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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
Time Frame:
Recruitment should start in December 2001 and is expected to last for approximately 9 months. Hence the data required to address the primary endpoint will be available 15 months after the start of recruitment. Data required to address the secondary endpoints will be available 21 months after the start of recruitment. Assuming that the WHO-appointed micronutrient laboratory will be able to report the results of vitamin A-related analyses within six weeks of the completion of specimen collection, all laboratory and statistical analyses will be completed within 4 months of finishing field activities.
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Primary Outcome(s)
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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
2. Incidence of each of the following:
2.1. Bulging fontanelle
2.2. Temperature greater than 37.5°C
2.3. Vomiting
2.4. Diarrhoea
2.5. Inability to suck/feed during the two days following each vitamin A supplementation
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Secondary Outcome(s)
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1. Mean serum retinol concentration at 6 months of age
2. Prevalence of VAD (any and severe) at 9 months of age
3. Mean retinol concentration at 9 months of age
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Secondary ID(s)
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WHO/RPC005
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Source(s) of Monetary Support
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World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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