Contact information
Type
Scientific
Primary contact
Prof M L Bennish
ORCID ID
Contact details
Africa Centre for Health and Population Studies
P.O. Box 198
Mtubatuba
3935
South Africa
+27 (0)35 550 7502
mbennish@africacentre.ac.za
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00133419
Protocol/serial number
5U01 AI058371-05 (grant number); NIH/NIAD
Study information
Scientific title
Acronym
Study hypothesis
Objective:
To compare the effect of three micronutrient supplements:
1. Vitamin A only,
2. Vitamin A and zinc,
3. A micronutrient mixture containing vitamins A, B, C, D, E, K, and calcium, copper, folate, iodine, iron, magnesium and zinc, on prevalent days of diarrhoea in three groups of children:
a. Human Immunodeficiency Virus (HIV)-infected children
b. HIV-uninfected children born to HIV-infected women
c. HIV-uninfected children born to women without HIV infection
Ethics approval
Not provided at time of registration
Study design
A randomised, double blind, clinical controlled trial with three arms
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Human Immunodeficiency Virus (HIV)
Intervention
Children from each of the HIV status groups will be individually randomised to one of the three multivitamin/micronutrient arms:
1. Vitamin A only
2. Vitamin A and zinc
3. A micronutrient mixture containing vitamins A, B, C, D, E, K, and calcium, copper, folate, iodine, iron, magnesium and zinc
Randomisation will occur in blocks of six within each of the HIV status groups. This will result in assigning a pre-coded box filled with blister packets of seven micronutrient tablets each. Each child will use tablets from that same box throughout the study. Each type of tablet will appear and taste identical to ensure blinding of both mothers and field staff. The interval between testing and randomisation may vary depending on the time required to obtain HIV testing results. All children will, however, start their respective supplement at six months of age (+/- 14 days) and will continue with the supplements until they are 24 months of age (i.e. for approximately 18 months). Monitoring will continue throughout this time to determine the long-term impact of each supplementation.
Intervention type
Supplement
Phase
Not Specified
Drug names
Micronutrient supplementation
Primary outcome measures
The primary outcome measure is prevalent days of diarrhoea per child during the 18 months that children will receive supplements (from six to 24 months of age). Comparisons will be stratified by HIV status, and all three micronutrient regimens will be compared within these strata.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/07/1999
Overall trial end date
30/06/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Infants aged four to six months (stratified by HIV status)
2. Able to take oral preparations
3. Parent/guardian able to give consent
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
516
Participant exclusion criteria
1. Documented micronutrient supplementation other than vitamin A in the preceding month
2. Less than 60% of mean weight for age by National Center for Health Statistics (NCHS) guidelines (micronutrient intervention obligatory according to World Health Organisation [WHO] guidelines for management of severely malnourished children)
3. Persistent diarrhoea (more than seven days) at the time of study enrolment
4. Exclusive breastfeeding
5. Infants in whom a second confirmatory HIV test cannot be obtained (when required)
6. Co-enrolment of the infant in other clinical intervention trials e.g. antibiotic or vaccine trials
Recruitment start date
01/07/1999
Recruitment end date
30/06/2005
Locations
Countries of recruitment
South Africa
Trial participating centre
Africa Centre for Health and Population Studies
Mtubatuba
3935
South Africa
Sponsor information
Organisation
National Institute of Allergy and Infectious Diseases (NIAID) (USA)
Sponsor details
International Tropical Disease Research Network
Division of Microbiology and Infectious Diseases (DMID)
Room 5067
6610 Rockledge Drive
Bethesda
20892
United States of America
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute of Allergy and Infectious Diseases (NIAID) (USA)
Alternative name(s)
NIAID
Funding Body Type
government organisation
Funding Body Subtype
federal/national government
Location
United States of America
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