ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Neovita

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Neonatal mortality

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

All cause early infant mortality (0-5 months) assessed by home visits to all study families and the administration of a questionnaire

Timepoint [1]

At 6 months of age

Primary outcome [2]

All cause neonatal mortality (0-1 month) assessed by home visits to all study families and the administration of a questionnaire

Timepoint [2]

1 month of age

Secondary outcome [1]

All cause hospitalisations assessed by home visits to all study families and the administration of a questionnaire

Timepoint [1]

At 6 months of age.

Secondary outcome [2]

All cause infant mortality (0-11 months) assessed by home visits to all study families and the administration of a questionnaire

Timepoint [2]

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

Sex

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

16/08/2010

Actual

16/08/2010

Date of last participant enrolment

Anticipated

Actual

7/11/2011

Date of last data collection

Anticipated

Actual

31/03/2013

Sample size

Target

32000

Accrual to date

Final

22955

Recruitment outside Australia

Country [1]

Ghana

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Bill and Melinda Gates Foundation

Address [1]

500 5th Ave North, Seattle, WA 98102

Country [1]

United States of America

Primary sponsor type

Other

Name

World Health Organization

Address

20 Avenue Appia, 1202, Geneva

Country

Switzerland

Secondary sponsor category [1]

Other

Name [1]

World Health Organization

Address [1]

20 Avenue Appia, 1202, Geneva

Country [1]

Switzerland

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

World Health Organization

Ethics committee address [1]

20 Avenue Appia, 1202, Geneva

Ethics committee country [1]

Switzerland

Date submitted for ethics approval [1]

Approval date [1]

01/11/2009

Ethics approval number [1]

Ethics committee name [2]

London School of Hygiene and Tropical Medicine

Ethics committee address [2]

1 Keppel St, London, WC1E7HT

Ethics committee country [2]

United Kingdom

Date submitted for ethics approval [2]

Approval date [2]

01/02/2010

Ethics approval number [2]

Ethics committee name [3]

Kintampo Health Research Centre Ghana

Ethics committee address [3]

1 Kintampo Main Street, Kintampo, Brong Ahafo, Ghana

Ethics committee country [3]

Ghana

Date submitted for ethics approval [3]

Approval date [3]

01/11/2009

Ethics approval number [3]

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

Prof Karen Edmond

Address

Princess Margaret Hospital for Children
1 Roberts Road Subiaco
Perth 6008
WA

Country

Australia

Phone

+61 402966962

Fax

karen.edmond@uwa.edu.au

Contact person for public queries

Name

Karen Edmond

Address

Princess Margaret Hospital for Children
1 Roberts Road Subiaco
Perth 6008
WA

Country

Australia

Phone

+ 61 402966962

Fax

karen.edmond@uwa.edu.au

Contact person for scientific queries

Name

Karen Edmond

Address

Princess Margaret Hospital for Children
1 Roberts Road Subiaco
Perth 6008
WA

Country

Australia

Phone

+ 61 402966962

Fax

karen.edmond@uwa.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Efficacy of early neonatal vitamin A supplementation in reducing mortality during infancy in Ghana, India and Tanzania: Study protocol for a randomized controlled trial.	2012	https://dx.doi.org/10.1186/1745-6215-13-22
Embase	Effect of early neonatal vitamin A supplementation on mortality during infancy in Ghana (Neovita): A randomised, double-blind, placebo-controlled trial.	2015	https://dx.doi.org/10.1016/S0140-6736%2814%2960880-1
Embase	Non-specific effects of BCG and DTP vaccination on infant mortality: An analysis of birth cohorts in Ghana and Tanzania.	2022	https://dx.doi.org/10.1016/j.vaccine.2022.04.082

N.B. These documents automatically identified may not have been verified by the study sponsor.

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