Condition category
Infections and Infestations
Date applied
21/11/2006
Date assigned
07/12/2007
Last edited
07/12/2007
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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Mnuts/supps/HIV/children

Study hypothesis

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

Approved by the Research Ethics Committee (REC) of the University of Cape Town on 03/12/2001 (ref: RECRES 118/2001).

Study design

Prospective, double-blind randomised, placebo-controlled clinical trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Vitamin and mineral supplementation

Primary outcome measures

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 trial start date

23/04/2002

Overall trial end date

26/11/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

495

Participant 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

Recruitment start date

23/04/2002

Recruitment end date

26/11/2004

Locations

Countries of recruitment

South Africa

Trial participating centre

Ambulatory Paediatrics
Cape Town
7700
South Africa

Sponsor information

Organisation

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

Sponsor details

Bristol-Myers Squibb
HIV Research Institute
47 van Buuren Road
Bedfordview
Gauteng
2008
South Africa
+27 (0)11 4566459
richardwanlass@bms.com

Sponsor type

Industry

Website

http://www.bms.com

Funders

Funder type

Industry

Funder name

Secure-the-Future Bristol-Myers Squibb (South Africa) (ref: RES094/02)

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