Contact information
Type
Scientific
Contact name
Dr Tracey Goodman
ORCID ID
Contact details
World Health Organization
20
Avenue Appia
Geneva-27
CH-1211
Switzerland
goodmant@who.int
Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Not specified
Study 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
Primary outcome measure
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 study start date
01/01/2004
Overall study end date
01/01/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Mothers normally resident in the study area
2. Informed consent obtained from the mother
Participant type(s)
Patient
Age group
Not Specified
Sex
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, Switzerland
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|