Micronutrients and enteric infections in African children: the effect of prophylactic micronutrient supplementation on morbidity and growth in human immunodeficiency virus infected and human immunodeficiency virus-uninfected children in South Africa

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus (HIV); Infections and Infestations; Immune diseases

• Registration Number: ISRCTN39226623
• Lead Sponsor: ational Institute of Allergy and Infectious Diseases (NIAID) (USA)

Brief Summary

1. 2007 results in https://www.ncbi.nlm.nih.gov/pubmed/17593956 (added 28/01/2019) 2. 2009 results in https://www.ncbi.nlm.nih.gov/pubmed/19174830 (added 28/01/2019) 3. 2010 results in https://www.ncbi.nlm.nih.gov/pubmed/20298571 (added 28/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-06-30
• Study Start: 2006-03-30
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 516

Inclusion Criteria

1. Infants aged four to six months (stratified by HIV status)
2. Able to take oral preparations
3. Parent/guardian able to give consent

Exclusion Criteria

1. Documented micronutrient supplementation other than vitamin A in the preceding month
2. Less than 60% of mean weight for age by National Center for Health Statistics (NCHS) guidelines (micronutrient intervention obligatory according to World Health Organisation [WHO] guidelines for management of severely malnourished children)
3. Persistent diarrhoea (more than seven days) at the time of study enrolment
4. Exclusive breastfeeding
5. Infants in whom a second confirmatory HIV test cannot be obtained (when required)
6. Co-enrolment of the infant in other clinical intervention trials e.g. antibiotic or vaccine trials

Study & Design

• Study Type: Interventional
• Study Design: Not specified