The Effect of Niacin Supplementation, Statin Medication and Nutrition Interventions on HIV-infected Children Receiving Anti-retroviral Therapy at Doctor George Mukhari Academic Hospital, Gauteng, South Africa

Not Applicable

• Conditions: HIV/AIDS; Paediatrics; Cardiology

• Registration Number: PACTR201810851895495
• Lead Sponsor: Prof Siyazi Mda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-12
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

All children who have been on ART for at least 6 months, who are attending the HIV clinic at DGMAH POPD and whose caregivers give consent, will be screened for dyslipidaemia. Those who test positive for dyslipidaemia will be enrolled (after obtaining informed consent) into the study. Non-probability convenience sampling will be used.

Exclusion Criteria

Children with an underlying disease that predisposes them to hyperlipidaemia (e.g. diabetes mellitus, nephrotic syndrome, chronic liver disease, familial hypercholesterolemia and hypothyroidism) will be excluded.
Poor adherence to ART (high pill count on hospital visits, current investigation for resistance testing, poor viral suppression), and those who are already on lipid lowering agents will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Significant change in blood lipid values as categorised by the National Cholesterol Education Program (NCEP) Adult Treatment Panel III; American Academy of Pediatrics (NCEP ATP III / AAP).

Secondary Outcome Measures

Name	Time	Method
Anthropometrical measures of physical growth. Weight, height, mid-upper arm circumference, waist circumference, hip circumference. ;Liver function tests and glucose test