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
Protocol serial number	N/A
Sponsor	Secure-The-Future Bristol-Myers Squibb (South Africa)
Funder	Secure-the-Future Bristol-Myers Squibb (South Africa) (ref: RES094/02)

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

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

Primary study design	Interventional
Study design	Prospective, double-blind randomised, placebo-controlled clinical trial.
Secondary study design	Randomised controlled trial
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(s)	Relative frequency of adverse or serious infective episodes, or death.
Key secondary outcome measure(s)	1. Viral load and CD4 count changes 2. Biochemical variables such as micronutrient levels measures 3. Relative frequency of minor infective episodes
Completion date	26/11/2004

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	6 Years
Sex	Not Specified
Target sample size at registration	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

Ambulatory Paediatrics

Cape Town
7700
South Africa

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan