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Trial registered on ANZCTR


Registration number
ACTRN12610000582055
Ethics application status
Approved
Date submitted
19/05/2010
Date registered
20/07/2010
Date last updated
1/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of newborn vitamin A supplementation in improving child survival in rural Ghana
Scientific title
Efficacy of newborn vitamin A supplementation in improving child survival in rural Ghana: generation of evidence necessary for informing global policy
Secondary ID [1] 252224 0
Nil
Universal Trial Number (UTN)
Trial acronym
Neovita
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal mortality 257397 0
Condition category
Condition code
Reproductive Health and Childbirth 257547 257547 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vitamin A 50,000 International Units (IU) once orally within the first 3 days of life
Intervention code [1] 256506 0
Prevention
Comparator / control treatment
Placebo capsule of soy bean oil with identical appearance to the intervention capsule once orally within the first 3 days of life
Control group
Placebo

Outcomes
Primary outcome [1] 258456 0
All cause early infant mortality (0-5 months) assessed by home visits to all study families and the administration of a questionnaire
Timepoint [1] 258456 0
At 6 months of age
Primary outcome [2] 258457 0
All cause neonatal mortality (0-1 month) assessed by home visits to all study families and the administration of a questionnaire
Timepoint [2] 258457 0
1 month of age
Secondary outcome [1] 264247 0
All cause hospitalisations assessed by home visits to all study families and the administration of a questionnaire
Timepoint [1] 264247 0
At 6 months of age.
Secondary outcome [2] 265444 0
All cause infant mortality (0-11 months) assessed by home visits to all study families and the administration of a questionnaire
Timepoint [2] 265444 0
at 12 months of age.

Eligibility
Key inclusion criteria
All births in the study area that are contacted by the study team on the day of birth or in the next 2 days will be eligible for inclusion in this study.

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

Infants will be included even if they were not identified during pregnancy surveillance
Minimum age
2 Hours
Maximum age
3 Days
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Babies will be excluded if any of the following criteria are met:
- Unable to feed on offering feeds, as reported by the mother
- 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)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The unit of randomization will be individual neonates. A randomization list will be prepared off-site, under the responsibility of the World Health Organization (WHO). Simple randomisation using a randomisation table created by computer software will be used i.e. computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2637 0
Ghana
State/province [1] 2637 0

Funding & Sponsors
Funding source category [1] 256992 0
Charities/Societies/Foundations
Name [1] 256992 0
Bill and Melinda Gates Foundation
Address [1] 256992 0
500 5th Ave North, Seattle, WA 98102
Country [1] 256992 0
United States of America
Primary sponsor type
Other
Name
World Health Organization
Address
20 Avenue Appia, 1202, Geneva
Country
Switzerland
Secondary sponsor category [1] 256534 0
Other
Name [1] 256534 0
World Health Organization
Address [1] 256534 0
20 Avenue Appia, 1202, Geneva
Country [1] 256534 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259002 0
World Health Organization
Ethics committee address [1] 259002 0
20 Avenue Appia, 1202, Geneva
Ethics committee country [1] 259002 0
Switzerland
Date submitted for ethics approval [1] 259002 0
Approval date [1] 259002 0
01/11/2009
Ethics approval number [1] 259002 0
Ethics committee name [2] 259003 0
London School of Hygiene and Tropical Medicine
Ethics committee address [2] 259003 0
1 Keppel St, London, WC1E7HT
Ethics committee country [2] 259003 0
United Kingdom
Date submitted for ethics approval [2] 259003 0
Approval date [2] 259003 0
01/02/2010
Ethics approval number [2] 259003 0
Ethics committee name [3] 259004 0
Kintampo Health Research Centre Ghana
Ethics committee address [3] 259004 0
1 Kintampo Main Street, Kintampo, Brong Ahafo, Ghana
Ethics committee country [3] 259004 0
Ghana
Date submitted for ethics approval [3] 259004 0
Approval date [3] 259004 0
01/11/2009
Ethics approval number [3] 259004 0

Summary
Brief summary
The primary objective of our study is to determine if vitamin A supplementation (50,000 international units (IU)) given to neonates once orally either on the day of birth or in the next 2 days will reduce mortality in the first half of infancy by at least 15% as compared to placebo. Secondary objectives are to: (i) To determine if vitamin A supplementation (50,000 IU) given to neonates once orally either on the day of birth or in the next 2 days will reduce mortality at 12 months by at least 15% as compared to placebo; (ii) determine the impact of the vitamin A supplementation on neonatal mortality (day 1-28); (iii) determine the impact of the vitamin A supplementation on the incidence of severe morbidity defined as hospitalisations due to any illness in the first 6 months of infancy; (iv) to document the potential adverse effects of vitamin A such as bulging fontanelle, vomiting, irritability, fever, diarrhea, inability to suck or feed, convulsions or any other condition that caused parents to be concerned, in the 3 days period following administration of the supplement and (v) to determine the vitamin A and C reactive protein (CRP) status of a subsample of infants at 2 weeks and 3 months of age in the vitamin A supplementation and placebo groups. This trial has been designed as an individually randomized, double-masked, placebo controlled efficacy trial. All infants randomized to the intervention group will receive 50,000 IU vitamin A either on the day of birth or in the next 2 days; the control group will receive a placebo. This study will be conducted over a 4 year period (Oct 2009 to Oct 2013) . The study area comprises 7 contiguous districts (Kintampo North, Kintampo South, Wenchi, Tain, Techiman, Nkoranza North and Nkoranza South) in the Brong Ahafo region of central rural Ghana, and covers 12,000 square kilometres. 70% of deliveries occur in health facilities in the study area. There will be four teams employed to work on this project: (i) 50 dosing supervisors who will be responsible for providing the vitamin A/placebo supplementation to the babies within 48 hours of birth and following up the babies day 1 and day 3 post supplementation (ii) 120 village based field workers who will be responsible for home visits and field surveillance of all women of reproductive age and monitoring outcomes in all study babies; (iii) a dedicated Information, Education, Communication (IEC) team who will be responsible for developing the birth notification system and liaising with the health facilities and communities included in the project; and (iv) a dedicated data management team who will be responsible for data entry and management of all questionnaires administered in this trial.

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
Edmond KM, Newton S, Shannon C, O'Leary M, Hurt L, Thomas G, Amenga-Etego S, Tawiah-Agyemang C, Gram L, Hurt CN, Bahl R, Owusu-Agyei S, Kirkwood BR. Effect of early neonatal vitamin A supplementation on mortality during infancy in Ghana (Neovita): a randomised, double-blind, placebo-controlled trial. Lancet 2014 Dec 10. pii: S0140-6736(14)60880-1. doi: 10.1016/S0140-6736(14)60880-1
Public notes

Contacts
Principal investigator
Name 31180 0
Prof Karen Edmond
Address 31180 0
Princess Margaret Hospital for Children
1 Roberts Road Subiaco
Perth 6008
WA
Country 31180 0
Australia
Phone 31180 0
+61 402966962
Fax 31180 0
Email 31180 0
karen.edmond@uwa.edu.au
Contact person for public queries
Name 14427 0
Prof Karen Edmond
Address 14427 0
Princess Margaret Hospital for Children
1 Roberts Road Subiaco
Perth 6008
WA
Country 14427 0
Australia
Phone 14427 0
+ 61 402966962
Fax 14427 0
Email 14427 0
karen.edmond@uwa.edu.au
Contact person for scientific queries
Name 5355 0
Prof Karen Edmond
Address 5355 0
Princess Margaret Hospital for Children
1 Roberts Road Subiaco
Perth 6008
WA
Country 5355 0
Australia
Phone 5355 0
+ 61 402966962
Fax 5355 0
Email 5355 0
karen.edmond@uwa.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary