Trial registered on ANZCTR


Trial ID
ACTRN12610000636055
Ethics application status
Approved
Date submitted
19/05/2010
Date registered
3/08/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of newborn vitamin A supplementation versus placebo in improving child survival in Tanzania
Scientific title
Efficacy of newborn vitamin A supplementation in improving child survival in Tanzania: generation of evidence necessary for informing global policy.
Secondary ID [1] 251805 0
RPC356(TANZANIA), issued by World Health Organization
Universal Trial Number (UTN)
Trial acronym
Neovita

Health condition
Health condition(s) or problem(s) studied:
Mortality in the first year of infancy 257398 0
Mortality in the neonatal period (from enrollment until day 28) 257399 0
Incidence of severe morbidity defined as hospitalizations due to any illness in the first year of infancy 257400 0
Adverse effects of vitamin A in the 3 days period following administration of the supplement 257401 0
Condition category
Condition code
Reproductive Health and Childbirth 257548 257548 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description 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.
Intervention code [1] 256507 0
Prevention
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.
Control group
Placebo

Outcomes
Primary outcome [1] 258458 0
Risk of death, assessed by parent interview
Timepoint [1] 258458 0
Period between receiving the intervention/placebo and 1 year
Secondary outcome [1] 264249 0
Risk of death, assessed by parent interview
Timepoint [1] 264249 0
Period between receiving the intervention/placebo and 28 days of age
Secondary outcome [2] 264250 0
Risk of hospital admission, assessed by parent interview
Timepoint [2] 264250 0
Period between receiving the intervention/placebo and 1 year.
Secondary outcome [3] 264251 0
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
Timepoint [3] 264251 0
Three day period following supplementation
Secondary outcome [4] 264252 0
Vitamin A status of newborns in the intervention and placebo groups in a small randomly selected subgroup, assessed by blood analysis.
Timepoint [4] 264252 0
Two weeks and three months of age

Eligibility
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.
Minimum age
2 Hours
Maximum age
2 Days
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy

Recruitment
Anticipated date of first participant enrolment
9/07/2010
Actual date of first participant enrolment
26/08/2010
Anticipated date last participant enrolled
Actual date last participant enrolled
3/03/2013
Target sample size
32000
Actual sample size
31999
Recruitment status
Closed: follow-up complete
Recruitment outside Australia
Country [1] 2638 0
Tanzania, United Republic Of
State/province [1] 2638 0

Funding & Sponsors
Funding source category [1] 256993 0
Charities/Societies/Foundations
Name [1] 256993 0
Bill and Melinda Gates Foundation (through WHO)
Address [1] 256993 0
PO Box 23350, Seattle, WA 98102
Country [1] 256993 0
United States of America
Funding source category [2] 256994 0
Other
Name [2] 256994 0
World Health Organization
Address [2] 256994 0
20 Avenue Appia, Geneva 1211
Country [2] 256994 0
Switzerland
Primary sponsor type
Other
Name
World Health Organization
Address
20 Avenue Appia, Geneva 1211
Country
Switzerland
Secondary sponsor category [1] 256257 0
None
Name [1] 256257 0
Address [1] 256257 0
Country [1] 256257 0
Other collaborator category [1] 1267 0
Other
Name [1] 1267 0
Ifakara Health Institute
Address [1] 1267 0
P. O. Box 78373
Dar es Salaam
Country [1] 1267 0
Tanzania, United Republic Of
Other collaborator category [2] 1268 0
University
Name [2] 1268 0
Muhimbili University Health and Allied Sciences (MUHAS)
Address [2] 1268 0
P.O. Box 65001
Dar es Salaam
Country [2] 1268 0
Tanzania, United Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259005 0
Harvard School of Public Health Institutional Review Board
Ethics committee address [1] 259005 0
Harvard School of Public Health
Office of Human Research Administration
1552 Tremont Street
Boston, MA 02120
Ethics committee country [1] 259005 0
United States of America
Date submitted for ethics approval [1] 259005 0
25/09/2009
Approval date [1] 259005 0
24/11/2009
Ethics approval number [1] 259005 0
18195
Ethics committee name [2] 259006 0
Ifakara Health Institute Institutional Review Board
Ethics committee address [2] 259006 0
PO Box 78373
Dar es Salaam
Ethics committee country [2] 259006 0
Tanzania, United Republic Of
Date submitted for ethics approval [2] 259006 0
25/09/2009
Approval date [2] 259006 0
06/11/2009
Ethics approval number [2] 259006 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31181 0
Dr Wafaie Fawzi
Address 31181 0
Harvard TH Chan School of Public Health
665 Huntington Avenue
Building 1, Room 1102
Boston, Massachusetts 02115
Country 31181 0
United States of America
Phone 31181 0
+1 617.432.5299
Fax 31181 0
Email 31181 0
mina@hsph.harvard.edu
Contact person for public queries
Name 14428 0
Dr Honorati Masanja
Address 14428 0
Ifakara Health Institute
P. O. Box 78373
Dar es Salaam
Country 14428 0
Tanzania, United Republic Of
Phone 14428 0
+255 22 2150503
Fax 14428 0
Email 14428 0
hmasanja@ihi.or.tz
Contact person for scientific queries
Name 5356 0
Dr Honorati Masanja
Address 5356 0
Ifakara Health Institute
P. O. Box 78373
Dar es Salaam
Country 5356 0
Tanzania, United Republic Of
Phone 5356 0
+255 22 2150503
Fax 5356 0
Email 5356 0
hmasanja@ihi.or.tz