Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201810851895495 Date of Approval: 30/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title 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
Official scientific title 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
Brief summary describing the background and objectives of the trial Most HIV infected children live in developing countries where resources are limited. Research evidence from developed countries is not always feasible or applicable to South African circumstances. There is a great need for research on this population to explore inexpensive and acceptable treatment interventions for managing the complications that arise from exposure to lifelong ART. Aim of the study To assess the effect of niacin supplementation, statin treatment and dietary intervention on dyslipidaemia in HIV-infected children who have been receiving ART for more than 6 months. Objectives 1. To evaluate the effect of niacin supplementation on dyslipidaemia in HIV-infected children aged 6 months to <10 years, who have been on ART for more than 6 months. 2. To determine the effect of dietary changes only on dyslipidaemia in HIV-infected children aged 6 months to <10 years, who have been on ART for more than 6 months 3. To evaluate the effect of statin-treatment on dyslipidaemia in HIV-infected children 10 to 18 years, who have been on ART for more than 6 months. 4. To assess the nutritional adequacy according to dietary intake and growth of HIV infected children who have dyslipidaemia, 6 months to 18 years, who have been on ART for more than 6 months.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Other
Anticipated trial start date 01/02/2019
Actual trial start date
Anticipated date of last follow up 29/02/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Niacin 500mg once per day 6 months 500 mg of Niacin (Vit B3) in white capsules, to be taken orally once per day. The capsule can also be broken open and the powder can be added into the participant's food. This group of participants will also receive dietary education on lowering their saturated fat intake. 40
Control Group Placebo 500mg Placebo once per day 6 months White capsules, identical-looking to the Niacin capsules. The capsules can be taken orally or broken open and the powder added to the participant's food. This group will also receive dietary education to lower their saturated fat intake. 40 Placebo
Experimental Group Statin 10mg Simvastatin once per day 1 tablet per day for 6 months Simvastatin is an established treatment for hyperlipidaemia. 80
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. 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. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 18 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/08/2018 Sekako Makgatho University Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
5th Floor, Clinical Pathology Building, Sefako Makgatho University, Molotlegi street, Garankuwa 0204 Pretoria 0204 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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). after 3 months of treatment, after 6 months of treatment
Secondary Outcome Anthropometrical measures of physical growth. Weight, height, mid-upper arm circumference, waist circumference, hip circumference. 3 months and 6 months after treatment
Secondary Outcome Liver function tests and glucose test monthly
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Doctor George Mukhari Academic Hospital Pediatric Outpatient Department and HIV clinic Dr George Mukhari Academic Hospital, Molotlegi street, Garankuwa Pretoria 0200 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Medical Research Council of South Africa MRC Francie van Zijl Drive Parowvallei Tygerberg Cape 7505 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof Siyazi Mda Dr Dora Nginza Hospital, Zwide Port Elizabeth 6204 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Hulisani Pfano Buasi Dr George Mukhari Academic Hospital, Molotlegi street, Garankuwa Pretoria 0204 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Siyazi Mda siyazi.mda@gmail.com +27823384406 Nelson Mandela University
City Postal code Country Position/Affiliation
Port Elizabeth South Africa Research Associate SMU Department of Human Nutrition and Dietetics
Role Name Email Phone Street address
Public Enquiries Estelle Viljoen estelle.viljoen@smu.ac.za +27722476037 Molotlegi street, Garankuwa
City Postal code Country Position/Affiliation
Pretoria 0204 South Africa Lecturer SMU Department of Human Nutrition and Dietetics
Role Name Email Phone Street address
Scientific Enquiries Frederick Veldman frederick.veldman@smu.ac.za +27125214186 SMU, Molotlegi street, Garankuwa
City Postal code Country Position/Affiliation
Pretoria 0204 South Africa Head of Department SMU Department of Human Nutrition and Dietetics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data will include the following variables: age, gender, ART regimen, ART duration, lipogram at baseline, 3months and 6 months after intervention started, anthropometrical measures at baseline, 3months and 6 months after intervention started, reported side-effects or adverse events. Clinical Study Report,Informed Consent Form,Study Protocol Will be available within 12 months of completion date of the study, and will be available for a time frame of one year. Persons who may request access: Participants in the trial. Academics interested in the raw data, for secondary analysis or further investigation. Process for requesting data: Prof Siyazi Mda will need to be contacted, as Primary Sponsor of this trial.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information