Condition category
Infections and Infestations
Date applied
20/03/2006
Date assigned
28/04/2006
Last edited
27/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Heloise Buys

ORCID ID

Contact details

Ambulatory Paediatrics
School of Child and Adolescent Health
Red Cross Children's Hospital
Klipfontein Road
Rondebosch
Cape Town
7700
South Africa
hbuys@ich.uct.ac.za

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

ZnsuppHIVChildren

Study hypothesis

Zinc deficiency is common in human immunodeficiency virus (HIV)-infected children and contributes to immune dysfunction; zinc supplementation can improve immune function.

Ethics approval

Approved by the Research Ethics Committee (REC) of the University of Cape Town on 19/04/2001, reference number: 004/2001

Study design

Double-blind randomised placebo-controlled three-arm trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Zinc

Primary outcome measures

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 trial start date

01/06/2002

Overall trial end date

31/07/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Convenience sample of 39 eligible children

Participant 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

Recruitment start date

01/06/2002

Recruitment end date

31/07/2003

Locations

Countries of recruitment

South Africa

Trial participating centre

Ambulatory Paediatrics
Cape Town
7700
South Africa

Sponsor information

Organisation

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

Sponsor details

Sawkins Road
Rondebosch
Cape Town
7700
South Africa

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

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

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

Publication citations

Additional files

Editorial Notes