Trial from ANZCTR


Trial ID ACTRN12610000636055
Trial Status: Registered
Date Submitted: 19/05/2010
Date Registered: 3/08/2010
Retrospectively registered

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Public title Efficacy of newborn vitamin A supplementation versus placebo in improving child survival in Tanzania
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Efficacy of newborn vitamin A supplementation in improving child survival in Tanzania: generation of evidence necessary for informing global policy.
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Secondary ID [1] 251805 0
RPC356(TANZANIA), issued by World Health Organization
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UTN
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Trial acronym Neovita
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Health condition(s) or problem(s) studied:
Mortality in the first year of infancy 257398 0
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Mortality in the neonatal period (from enrollment until day 28) 257399 0
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Incidence of severe morbidity defined as hospitalizations due to any illness in the first year of infancy 257400 0
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Adverse effects of vitamin A in the 3 days period following administration of the supplement 257401 0
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Condition category: Condition code:
Reproductive Health and Childbirth Complications of newborn
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257548 257548 0 0

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Descriptions of intervention(s) / exposure 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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Intervention Code:
Prevention 256507 0
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Comparator / control treatment Placebo given orally as a single dose to neonates on the day of birth or in the next 2 days of birth. The placebo capsules will contain minute amounts of vitamin E in soybean oil.
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Control group Placebo
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Primary Outcome: Risk of death, assessed by parent interview 258458 0
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Timepoint: Period between receiving the intervention/placebo and 1 year 258458 0
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Secondary Outcome: Risk of death, assessed by parent interview 264249 0
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Timepoint: Period between receiving the intervention/placebo and 28 days of age 264249 0
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Secondary Outcome: Risk of hospital admission, assessed by parent interview 264250 0
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Timepoint: Period between receiving the intervention/placebo and 1 year. 264250 0
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Secondary Outcome: 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 264251 0
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Timepoint: Three day period following supplementation 264251 0
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Secondary Outcome: Vitamin A status of newborns in the intervention and placebo groups in a small randomly selected subgroup, assessed by blood analysis. 264252 0
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Timepoint: Two weeks and three months of age 264252 0
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Key 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.
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Minimum age 2 Hours
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Maximum age 2 Days
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Gender Both males and females
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Healthy volunteers? Yes
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Key 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
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) A master randomization sequence list will be prepared by off-site a priori. The randomization lists will be used for individually packaging and labeling the vitamin A/placebo doses for each enrolled newborn. Two capsules will be packed in a blister pack, one for the dose and the second for the backup dose. The blister packing, shape, size and color of the vitamin A and placebo capsules will be similar. Labels will be printed with the site and subject ID. Each participant will be assigned to the next regimen number in sequence at enrollment.

After becoming aware of a birth (when visiting the health facilities daily) or when notified of a birth by a key informant in the community, the Enrollment Research Assistant (ERA) will meet the newborn's parents between two hours and two days after birth. The ERA will do that either at the facility where birth as occurred or at the infant's home. The ERA will administer the enrollment consent form to mothers at this time if they were not identified to participate in the study through pregnancy surveillance. If the mother provides informed written consent to participate in the study, the newborn will be screened for the eligibility and exclusion criteria and enrolled in the study. Enrollment information such as date of birth, multiple births, birth weight, sex, and timing of initiation of breastfeeding will be collected. If the infant is eligible for enrollment, an identification number or a subject ID will be allocated and the vitamin A or placebo capsule administered.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) A randomization list will be prepared off-site, under the responsibility of the World Health Organization (WHO). The method of sequence generation to be used is permuted block randomization.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Safety/efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 9/07/2010
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 32000
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

Country: Tanzania, United Republic Of 2638 0
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State/Province: 2638 0
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Funding Source: Charities/Societies/Foundations 256993 0
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Name: Bill and Melinda Gates Foundation (through WHO) 256993 0
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Address: PO Box 23350, Seattle, WA 98102 256993 0
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Country: United States of America 256993 0
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Funding Source: Other 256994 0
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Name: World Health Organization 256994 0
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Address: 20 Avenue Appia, Geneva 1211 256994 0
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Country: Switzerland 256994 0
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Primary Sponsor Other
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Name: World Health Organization
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Address: 20 Avenue Appia, Geneva 1211
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Country: Switzerland
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Secondary Sponsor: None 256257 0
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Name: 256257 0
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Address: 256257 0
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Country: 256257 0
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Other Collaborator: Other 1267 0
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Name: Ifakara Health Institute 1267 0
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Address: P. O. Box 78373
Dar es Salaam
1267 0
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Country: Tanzania, United Republic Of 1267 0
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Other Collaborator: University 1268 0
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Name: Muhimbili University Health and Allied Sciences (MUHAS) 1268 0
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Address: P.O. Box 65001
Dar es Salaam
1268 0
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Country: Tanzania, United Republic Of 1268 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Harvard School of Public Health Institutional Review Board 259005 0
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Address: Harvard School of Public Health
Office of Human Research Administration
1552 Tremont Street
Boston, MA 02120
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Country: United States of America 259005 0
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Approval Date: 24/11/2009 259005 0
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Submitted Date: 25/09/2009 259005 0
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HREC: 18195 259005 0
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Ethics Committee name: Ifakara Health Institute Institutional Review Board 259006 0
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Address: PO Box 78373
Dar es Salaam
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Country: Tanzania, United Republic Of 259006 0
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Approval Date: 06/11/2009 259006 0
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Submitted Date: 25/09/2009 259006 0
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HREC: 259006 0
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Brief summary Subgroup analyses will include the effect of vitamin A supplementation in LBW and non LBW infants, male and female infants, immunised and unimmunised infants,
infants of families in the poorest and richest quintiles, and by vitamin A intake of mothers. For all deaths verbal autopsy interviews will be conducted.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Honorati Masanja
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Address: Ifakara Health Institute P. O. Box 78373 Dar es Salaam
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Country: Tanzania, United Republic Of
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Tel: +255 22 2150503
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Email: hmasanja@ihi.or.tz
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Contact person for scientific queries
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Name: Honorati Masanja
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Address: Ifakara Health Institute P. O. Box 78373 Dar es Salaam
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Country: Tanzania, United Republic Of
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Email: hmasanja@ihi.or.tz
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Contact person responsible for updating information
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Name: Wafaie Fawzi
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Address: 655 Huntington Avenue Building II Room 329A Boston, MA 02115
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Country: United States of America
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Fax: +1 617-432-1355
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Email: mina@hsph.harvard.edu
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Addition Cancer fields
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