Vitamin D and Cardiovascular Events in Rheumatoid Arthritis

NCT ID: NCT02932644

Last Updated: 2016-10-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1999-10-31
• Study Completion Date: 2016-10-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Rheumatoid arthritis patients

Participants in the original, parental trial

Baseline serum vitamin D level below 50 nmol/l

Intervention Type: OTHER

There is no medical intervention. The two groups are simple allocated depending on serum levels of D-total at the time of diagnosis

Baseline serum vitamin D level at or above 50 nmol/l

Intervention Type: OTHER

There is no medical intervention. The two groups are simple allocated depending on serum levels of D-total at the time of diagnosis

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Danish Rheumatism Association

OTHER

Sponsor Role: collaborator

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Region of Southern Denmark

OTHER

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Odense Patient Data Explorative Network

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mette Herly

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Torkell Ellingsen, MD, Phd

Role: STUDY_CHAIR

Odense University Hospital

Other Identifiers

3-3013-930/1/

Identifier Type: -

Identifier Source: org_study_id