NCT02932644

Vitamin D and Cardiovascular Events in Rheumatoid Arthritis

Association Between Baseline Vitamin D Metabolite Levels and Risk of Cardiovascular Events in Rheumatoid Arthritis Patients. A Cohort Study With Patient-record Evaluated Outcomes.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 160 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate cardiovascular events during long-term follow-up in Rheumatoid Arthritis. The primary outcome "any cardiovascular event" will be evaluated using systematic audits of patient records, and will be associated to low levels of vitamin D at baseline, to investigate the hypothesis that low levels of vitamin D can be part of a prediction model for cardiovascular disease in Rheumatoid Arthritis.

Detailed description

Cardiovascular morbidity and mortality is increased in patients with rheumatoid arthritis (RA), and among these patients, the prevalence of hypo-vitaminosis D is high. Low levels of vitamin D have been associated with elevated cardiovascular risk in healthy subjects. The objective of this study is to evaluate the risk of cardiovascular events in patients having low 25OHD-total levels at baseline compared to patients with sufficient levels, in an aggressively treated closed cohort of early-diagnosed RA patients. The primary outcome will be the proportion of patients with any cardiovascular event, evaluated using systematic journal audits. Logistic regression models will be applied to test the hypothesis that there are more cardiovascular events in patients enrolled with a low level of vitamin D (\< 50 nmol/l). Secondarily, Cox regression models, based on survival analysis, will be applied, to determine the extent to which independent variables (including different levels of vitamin D at baseline) predict not only whether a cardiovascular event occur, but also when it will occur.

Conditions

• Rheumatoid Arthritis
• Cardiovascular Disease

Interventions

Type	Name	Description
OTHER	Baseline serum vitamin D level below 50 nmol/l	There is no medical intervention. The two groups are simple allocated depending on serum levels of D-total at the time of diagnosis
OTHER	Baseline serum vitamin D level at or above 50 nmol/l	There is no medical intervention. The two groups are simple allocated depending on serum levels of D-total at the time of diagnosis

Timeline

• Start date: 1999-10-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-10-13
• Last updated: 2016-10-13