Safety of zinc supplementation in HIV-infected children

ISRCTN	ISRCTN56894409
DOI	https://doi.org/10.1186/ISRCTN56894409
Secondary identifying numbers	N/A

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

Email	hbuys@ich.uct.ac.za

Study design	Double-blind randomised placebo-controlled three-arm trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	ZnsuppHIVChildren
Study objectives	Zinc deficiency is common in human immunodeficiency virus (HIV)-infected children and contributes to immune dysfunction; zinc supplementation can improve immune function.
Ethics approval(s)	Approved by the Research Ethics Committee (REC) of the University of Cape Town on 19/04/2001, reference number: 004/2001
Health condition(s) or problem(s) studied	Zinc supplementation of HIV-1 infected children
Intervention	Patients are randomised into one of the three arms: Group A - placebo Group B - low dose zinc supplement Group C - high dose zinc supplement Trial drugs are given orally daily over 6 weeks and children are seen weekly for 12 weeks from start to end of the study.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Zinc
Primary outcome measure	1. No increase in viral loads 2. No reduction in CD4 counts 3. No deaths 4. Laboratory indicators of safety
Secondary outcome measures	1. An improvement in immune function on zinc supplementation 2. A reduction in infective events 3. A reduction in admissions to hospital
Overall study start date	01/06/2002
Completion date	31/07/2003

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	6 Years
Sex	Both
Target number of participants	Convenience sample of 39 eligible children
Key inclusion criteria	1. Clinically stable 2. Vertically transmitted HIV-1 infected children 3. Attending the Infectious Diseases Clinic at Red Cross Children's Hospital 4. Aged 6 months to 6 years
Key exclusion criteria	1. HIV-infected children aged less than 6 months 2. Children with an intercurrent infection or axillary temperature of >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 8 weeks 6. Children recently hospitalised
Date of first enrolment	01/06/2002
Date of final enrolment	31/07/2003

Ambulatory Paediatrics

Cape Town
7700
South Africa

University of Cape Town, The Child Health Unit (South Africa)
University/education

Sawkins Road
Rondebosch
Cape Town
7700
South Africa

"ROR"	https://ror.org/03p74gp79

University/education

Internally funded trial - The Child Health Unit, University of Cape Town (South Africa)

No information available

Intention to publish date
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