Vitamin and mineral supplementation in reducing morbidity in Human Immunodeficiency Virus (HIV)-infected children in developing countries: an efficacy study

ISRCTN ISRCTN79227925
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

Ambulatory Paediatrics
School of Child and Adolescent Health
Red Cross Children's Hospital
Klipfontein Road
Rondebosch
Cape Town
7700
South Africa

Study information

Study designProspective, double-blind randomised, placebo-controlled clinical trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymMnuts/supps/HIV/children
Study objectivesMicronutrient 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) studiedMicronutrient supplementation of HIV-1-infected children
InterventionPatients 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 typeSupplement
Primary outcome measureRelative frequency of adverse or serious infective episodes, or death.
Secondary outcome measures1. Viral load and CD4 count changes
2. Biochemical variables such as micronutrient levels measures
3. Relative frequency of minor infective episodes
Overall study start date23/04/2002
Completion date26/11/2004

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
Upper age limit6 Years
SexNot Specified
Target number of participants495
Key inclusion criteria1. 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 criteria1. 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 enrolment23/04/2002
Date of final enrolment26/11/2004

Locations

Countries of recruitment

  • South Africa

Study participating centre

Ambulatory Paediatrics
Cape Town
7700
South Africa

Sponsor information

Secure-The-Future Bristol-Myers Squibb (South Africa)
Industry

Bristol-Myers Squibb
HIV Research Institute
47 van Buuren Road
Bedfordview
Gauteng
2008
South Africa

Phone +27 (0)11 4566459
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan