Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/11/2004
Date assigned
24/11/2004
Last edited
26/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tracey Goodman

ORCID ID

Contact details

World Health Organization
20
Avenue Appia
Geneva-27
CH-1211
Switzerland
goodmant@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The primary objectives of the proposed trial are to:
1. Measure the effect of 400,000 IU of vitamin A given in two divided doses of 200,000 IU to mothers, and 3 doses of 50,000 IU of vitamin A given to their infants concurrently with Diphtheria, Pertussis and Tetanus (DPT)/Polio immunisations, on vitamin A status of the infants at 26 weeks of age
2. Compare the effect of such a regimen to that of the previously recommended regimen of 200,000 IU of vitamin A given to mothers and 3 doses of 25,000 IU of vitamin A given to their infants concurrently with DPT/Polio immunisations
3. Measure the side effects of 50,000 IU of vitamin A administered with DPT/Polio immunisations

The outcomes to be monitored for the above objectives include serum retinol levels, modified Retinol Dose Response (mRDR) tests, incidence of side effects such as bulging of the anterior fontanel and vomiting, and incidence of severe morbidity.

The secondary objectives are to:
4. Measure the effect of the maternal dose on breast milk retinol levels up to 9 months post partum
5. Examine if any impacts on infant vitamin A status are sustained beyond 6 months of age up to 9 months of age

Outcomes to be monitored for the secondary objectives include breast milk retinol concentrations and mRDR testing of infants at 9 months of age.

Related to the main objectives, the following hypotheses will be tested:
1. Giving 400,000 IU of vitamin A to mothers within 6 weeks of delivery, plus 50,000 IU given to their infants with their DPT/Polio immunisations, will improve infants' vitamin A status as measured by mean serum retinol, or by proportions below 20 ug/dl, or proportions of abnormal mRDR at 6 months of age. The proportion of infants with serum retinol concentration below 20 ug/dl will be reduced by 66% from 43%, which was achieved by the 25,000 IU-dosing regimen. Similarly, the proportion of infants with mRDR ratio greater than or equal to 0.06 will be reduced by 66% from 44%, which was achieved by 25,000 IU-dosing regimen.
2. Giving 50,000 IU of vitamin to infants with their DPT/Polio immunisations will produce no clinically significant side effects

The following additional hypotheses will be tested for the secondary objectives:
3. Giving 400,000 IU of vitamin to mothers in the post partum period will result in a greater improvement in breast milk retinol levels than that achieved with 200,000 IU, and that this improvement will be sustained up to 9 months
4. The improvement to infant vitamin A status at 6 months of age, due to the newly proposed supplementation regime, will be sustained beyond 6 months up to 9 months of age

Ethics approval

Ethics approval received from:
1. Ethical Review Committee of the Ministry of Health (Ghana) on the 24th September 2001
2. London School of Hygiene and Tropical Medicine Ethics Committee on the 29th April 2002

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Vitamin A Deficiency

Intervention

1st Group:
1. Mothers 200,000 IU Vitamin A shortly after delivery
2. Infants: 25,000 IU Vitamin A with each Diphtheria, Pertussis, Tetanus (DPT) vaccine 1, 2 and 3

2nd Group:
1. Mothers 200,000 IU Vitamin A at infant's Bacillus Calmette-Guerin (BCG) vaccine and another 200,000 IU Vitamin A at infant's 1st DPT
2. Infants: 50,000 IU Vitamin A with each DPT 1, 2 and 3

Intervention type

Supplement

Phase

Not Specified

Drug names

Vitamin A supplementation

Primary outcome measures

1. Serum retinol levels, assessed by carrying out mRDR testing of infants at 6 weeks, 6 months and 9 months
2. Modified Retinol Dose Response (mRDR) tests
3. Incidence of side effects such as bulging of the anterior fontanel and vomiting
4. Incidence of severe morbidity

Secondary outcome measures

1. Breast milk retinol concentrations, assessed at 6 weeks, 6 months and 9 months for an assessment of the impact of the different supplementation regimes
2. mRDR testing of infants at 9 months of age

Overall trial start date

01/01/2004

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Mothers normally resident in the study area
2. Informed consent obtained from the mother

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

1,400 mother-infant pairs.

Participant exclusion criteria

1. Mothers unable to give informed consent
2. Mothers considered to be at high risk of adverse outcome in puerperal period
3. Multiple deliveries
4. Severe adverse reaction to vitamin A supplementation

Recruitment start date

01/01/2004

Recruitment end date

01/01/2006

Locations

Countries of recruitment

Ghana

Trial participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)

Sponsor details

20
Avenue Appia
Geneva-27
CH-1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int

Funders

Funder type

Research organisation

Funder name

World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes