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

Completed

• Conditions: Micronutrient supplementation of HIV-1-infected children; Infections and Infestations; Human Immunodeficiency Virus (HIV)

• Registration Number: ISRCTN79227925
• Lead Sponsor: Secure-The-Future Bristol-Myers Squibb (South Africa)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-07
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 495

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative frequency of adverse or serious infective episodes, or death.

Secondary Outcome Measures

Name	Time	Method
1. Viral load and CD4 count changes<br>2. Biochemical variables such as micronutrient levels measures<br>3. Relative frequency of minor infective episodes