Effect of antioxidant and statin supplementation on endothelial function and cardiovascular markers among people with HIV in Nigeria: A protocol for a randomised controlled trial.

The trial uses a four-arm design with 100 total participants divided equally across groups.

• 100 participants total, with 25 in each of the four groups
• The four groups are: antioxidant supplementation, statin supplementation, combined antioxidant and statin supplementation, and placebo
• The study is randomised, double-blind, and placebo-controlled
• The trial is conducted among HIV-positive individuals in Nigeria

The primary outcomes include endothelial function, blood pressure, pulse rate, lipid markers, and inflammatory markers.

• Endothelial function is assessed by brachial artery flow-mediated dilation (FMD)
• Lipid markers include LDL cholesterol, HDL cholesterol, total cholesterol, and triglycerides
• Inflammatory marker measured is highly sensitive-C-reactive protein (hs-CRP)
• Blood pressure and pulse rate are also designated as primary outcomes

Data collection includes baseline and follow-up assessments at 1, 3, and 6 months.

• Blood samples will be collected at each time point to measure cardiovascular markers
• Endothelial function will be assessed using brachial artery flow-mediated dilatation at each assessment point
• The total follow-up duration is 6 months

Statistical analysis will follow intention-to-treat principles with multiple analytical approaches.

• Group differences for continuous variables will be assessed using ANOVA or Kruskal-Wallis test
• Categorical variables will be assessed using Chi-square or McNemar test
• Multivariable regression models will be used to adjust for confounding

People living with HIV face a heightened risk of cardiovascular disease, with endothelial dysfunction playing a critical role in its development.

• The study background identifies endothelial dysfunction as a critical mechanism linking HIV and cardiovascular disease
• Antioxidants and statins have shown promise in improving endothelial function and reducing cardiovascular risk in prior work
• The long-term effect of these interventions on HIV-positive individuals remains unclear according to the authors

The study is hypothesized to provide evidence that antioxidant and statin supplementation improves endothelial function and cardiovascular health in Nigerian HIV patients.

• If successful, findings could inform clinical guidelines and interventions to reduce cardiovascular risk in this population
• The study aims to assess both individual and combined effects of the two supplementation types
• The trial is specifically situated in a Nigerian HIV patient population, addressing a gap in evidence from sub-Saharan Africa