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Impact of Antioxidant and Statin Supplementation on Endothelial Function and Cardiovascular Markers among People with HIV in Nigeria

Impact of Antioxidant and Statin Supplementation on Endothelial Function and Cardiovascular Markers among People with HIV in Nigeria: A Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
PACTR
Registry ID
PACTR202507849409471
Enrollment
200
Registered
2025-07-14
Start date
2025-07-17
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulatory System HIV/AIDS

Interventions

statins and anti oxidants supplementation groups
control
Statin only group
Antioxidant only group

Sponsors

Africa Center of Excellence for Population Health and Policy
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion Criteria Participants must meet all of the following to be eligible: 1. Adults aged 18 to 65 years. 2. Confirmed diagnosis of HIV infection using standard national testing algorithms. 3. On stable antiretroviral therapy (ART) for at least 6 months before enrollment. 4. Viral load < 1,000 copies/mL within the last 6 months (suppressed or controlled HIV). 5. Willing and able to provide written informed consent. 6. Able to comply with the study protocol, including clinic visits, blood sample collections, and ultrasound procedures. 7. Not currently on statin or antioxidant supplements.

Exclusion criteria

Exclusion criteria: Exclusion Criteria Participants will be excluded if they meet any of the following: 1. History of cardiovascular events, including myocardial infarction, stroke, or revascularization procedures. 2. Known diabetes mellitus or uncontrolled hypertension (BP =160/100 mmHg). 3. Current or recent (within 3 months) use of statins, antioxidants, or any lipid-lowering or anti-inflammatory therapy. 4. Pregnant or breastfeeding women. 5. Known renal impairment (eGFR 3× upper limit of normal). 6. History of statin intolerance, myopathy, or rhabdomyolysis. 7. Current active opportunistic infections or malignancies requiring treatment. 8. Enrolled in another clinical trial within the last 3 months. 9. Any condition deemed by the investigator to compromise participant safety or the integrity of the study.

Design outcomes

Primary

MeasureTime frame
Endothelial function will be assessed using brachial artery flow-mediated dilation (FMD), a well-established ultrasonographic measure of vascular reactivity.

Secondary

MeasureTime frame
Hemodynamic parameters: Systolic and diastolic blood pressure, pulse rate. Lipid profile: Serum levels of low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, total cholesterol, and triglycerides, measured via enzymatic assays. Inflammatory markers: Serum C-reactive protein (CRP).

Countries

Nigeria

Contacts

Public ContactUmar ;Aisha Sharif Abdussalam;M Nalado

Senior Lecturer;PROFESSOR

usabdussalam.pha@buk.edu.ng;aishnld@yahoo.co.uk+2348066930736;+2348065548503

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026