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Main
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Note: This record shows only the 20 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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ANZCTR |
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Last refreshed on:
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22 February 2013 |
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Main ID: |
ACTRN12610000636055 |
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Date of registration:
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03/08/2010 |
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Primary sponsor: |
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Public title:
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Efficacy of newborn vitamin A supplementation versus placebo in improving child survival in Tanzania
Neovita |
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Scientific title:
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Efficacy of newborn vitamin A supplementation in improving child survival in Tanzania: generation of evidence necessary for informing global policy. |
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Date of first enrolment:
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9/07/2010 |
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Target sample size:
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32000 |
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Recruitment status: |
Recruiting |
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URL:
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http://www.anzctr.org.au/ACTRN12610000636055.aspx |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial
Parallel |
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Countries of recruitment
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Tanzania, United Republic Of
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Contacts
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Name:
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Honorati Masanja |
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Address:
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Ifakara Health Institute
P. O. Box 78373
Dar es Salaam, Tanzania, United Republic Of
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Telephone:
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+255 22 2150503 |
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Email:
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hmasanja@ihi.or.tz |
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Affiliation:
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Name:
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Honorati Masanja |
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Address:
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Ifakara Health Institute
P. O. Box 78373
Dar es Salaam, Tanzania, United Republic Of
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Telephone:
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+255 22 2150503 |
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Email:
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hmasanja@ihi.or.tz |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1.) All births in the study area that are between two hours and two days of age, whose caretakers confirm of intention to remain in the study areas for a minimum of six months thereafter, will be eligible for inclusion in this study.
2.) Both singleton and multiple births are eligible for inclusion in this study and each infant will be provided with their own unique study identification number.
3.) Infants will be included even if they were not identified during pregnancy surveillance.
Exclusion criteria: 1.) Unable to feed if offered feeds as reported by the mother
2.) Mother does not intend to stay in the study area for at least 6 months
Age minimum:
2 Hours
Age maximum:
2 Days
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Adverse effects of vitamin A in the 3 days period following administration of the supplement
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Incidence of severe morbidity defined as hospitalizations due to any illness in the first year of infancy
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Mortality in the first year of infancy
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Mortality in the neonatal period (from enrollment until day 28)
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Intervention(s)
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Vitamin A supplementation, 50,000 International Units given orally as a single dose to neonates on the day of birth or in the next 2 days following birth. The active ingredients in the vitamin A capsules will be retinol palmitate (50,000 IU) and minute amounts of vitamin E in soybean oil.
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Primary Outcome(s)
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Risk of death, assessed by parent interview
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Secondary Outcome(s)
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Proportion of newborns with adverse events such as bulging fontanelle, vomiting, irritability, fever, diarrhea, inability to suck or feed, convulsions or any other conditions that cause parents to be concerned, assessed by parent interview and direct examination of the infant
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Risk of death, assessed by parent interview
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Risk of hospital admission, assessed by parent interview
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Vitamin A status of newborns in the intervention and placebo groups in a small randomly selected subgroup, assessed by blood analysis.
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Secondary ID(s)
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RPC356(TANZANIA), issued by World Health Organization
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Source(s) of Monetary Support
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World Health Organization
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Bill and Melinda Gates Foundation (through WHO)
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