Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Mnuts/supps/HIV/children
Study hypothesis
Micronutrient deficiencies contribute to immune dysfunction and can lead to increased infectious morbidity in Human Immunodeficiency Virus (HIV)-1-infected children. We hypothesised that micronutrient supplementation could reduce infectious morbidity in HIV-1-infected children.
Ethics approval
Approved by the Research Ethics Committee (REC) of the University of Cape Town on 03/12/2001 (ref: RECRES 118/2001).
Study design
Prospective, double-blind randomised, placebo-controlled clinical trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Micronutrient supplementation of HIV-1-infected children
Intervention
Patients are randomised into one of the three arms:
Group A - placebo
Group B - trace element supplement
Group C - high dose zinc supplement (3 mg/kg elemental zinc)
Trial drugs are given orally daily over six months and children are seen monthly for 12 weeks from start to end of the study.
Intervention type
Supplement
Phase
Not Specified
Drug names
Vitamin and mineral supplementation
Primary outcome measures
Relative frequency of adverse or serious infective episodes, or death.
Secondary outcome measures
1. Viral load and CD4 count changes
2. Biochemical variables such as micronutrient levels measures
3. Relative frequency of minor infective episodes
Overall trial start date
23/04/2002
Overall trial end date
26/11/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Clinically stable (not acutely ill)
2. Vertically transmitted HIV-1 infected children
3. Attending the Infectious Diseases Clinic at Red Cross Children's Hospital
4. Aged six months to six years
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
495
Participant exclusion criteria
1. HIV-infected children aged less than six months
2. Children with an intercurrent infection or axillary temperature of more than 38°C
3. Children with any invasive opportunistic infection including tuberculosis
4. Children with bronchiectasis
5. Children who had received high dose vitamin A, trace elements or zinc supplements within the preceding eight weeks
6. Children recently hospitalised within the preceding six weeks
Recruitment start date
23/04/2002
Recruitment end date
26/11/2004
Locations
Countries of recruitment
South Africa
Trial participating centre
Ambulatory Paediatrics
Cape Town
7700
South Africa
Sponsor information
Organisation
Secure-The-Future Bristol-Myers Squibb (South Africa)
Sponsor details
Bristol-Myers Squibb
HIV Research Institute
47 van Buuren Road
Bedfordview
Gauteng
2008
South Africa
+27 (0)11 4566459
richardwanlass@bms.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Secure-the-Future Bristol-Myers Squibb (South Africa) (ref: RES094/02)
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