Vitamin and mineral supplementation in reducing morbidity in Human Immunodeficiency Virus (HIV)-infected children in developing countries: an efficacy study
ISRCTN | ISRCTN79227925 |
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DOI | https://doi.org/10.1186/ISRCTN79227925 |
Secondary identifying numbers | N/A |
- Submission date
- 21/11/2006
- Registration date
- 07/12/2007
- Last edited
- 07/12/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Heloise Buys
Scientific
Scientific
Ambulatory Paediatrics
School of Child and Adolescent Health
Red Cross Children's Hospital
Klipfontein Road
Rondebosch
Cape Town
7700
South Africa
Study information
Study design | Prospective, double-blind randomised, placebo-controlled clinical trial. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study acronym | Mnuts/supps/HIV/children |
Study objectives | 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(s) | Approved by the Research Ethics Committee (REC) of the University of Cape Town on 03/12/2001 (ref: RECRES 118/2001). |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 23/04/2002 |
Completion date | 26/11/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 6 Months |
Upper age limit | 6 Years |
Sex | Not Specified |
Target number of participants | 495 |
Key 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 |
Key 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 |
Date of first enrolment | 23/04/2002 |
Date of final enrolment | 26/11/2004 |
Locations
Countries of recruitment
- South Africa
Study participating centre
Ambulatory Paediatrics
Cape Town
7700
South Africa
7700
South Africa
Sponsor information
Secure-The-Future Bristol-Myers Squibb (South Africa)
Industry
Industry
Bristol-Myers Squibb
HIV Research Institute
47 van Buuren Road
Bedfordview
Gauteng
2008
South Africa
Phone | +27 (0)11 4566459 |
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richardwanlass@bms.com | |
Website | http://www.bms.com |
Funders
Funder type
Industry
Secure-the-Future Bristol-Myers Squibb (South Africa) (ref: RES094/02)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |