Association between baseline vitamin D metabolite levels and long-term cardiovascular events in patients with rheumatoid arthritis from the CIMESTRA trial: protocol for a cohort study with patient-record evaluated outcomes.

What Was Tested

The paper reports a study of Vitamin D, K2, Magnesium and Zinc in the context of rheumatoid arthritis, published as a randomized controlled trial.

To evaluate the long-term risk of cardiovascular events in patients having low total 25-hydroxyvitamin D levels at baseline compared with patients with normal levels, in an efficiently treated, closed cohort of patients with an early diagnosis of RA.

Why It Was Studied

All patients have received verbal and written information before enrolment, and have given written consent at baseline.

To disseminate comprehension of factors of prognostic importance to cardiovascular outcome in RA, the researchers will attempt to have a first draft ready no later than 1 year after the adjudication process has finished.

Who Took Part

The abstract describes 160 patients taking part.

The age groups tagged for this paper are adults, middle-aged adults and older adults, both men and women.

This study is a prospective, closed, blinded endpoint cohort study, based on secondary analyses from a previous randomised trial (CIMESTRA study; NCT00209859, approved September 1999) including 160 patients with an early diagnosis of RA from Danish University clinics.

Primary outcome will be the proportion of patients with any cardiovascular event in the follow-up period, evaluated using systematic journal audits.

How the Study Was Run

The researchers set it up as a randomized study.

Because people in this Vitamin D, K2, Magnesium and Zinc study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Secondarily, Cox regression models, based on survival analysis, will determine the extent to which independent variables (including different levels of vitamin D at baseline) predict whether a cardiovascular event will occur, and also when this will be.

What Was Measured

To disseminate comprehension of factors of prognostic importance to cardiovascular outcome in RA, the researchers will attempt to have a first draft ready no later than 1 year after the adjudication process has finished.

If low vitamin D levels can predict cardiovascular events in RA, it is relevant to take into account in a prediction model, to be considered by patients, physicians and other decision-makers.

PubMed files the paper under topics including Arthritis, Rheumatoid, Biomarkers, Cardiovascular Diseases, Denmark, Patient Outcome Assessment, Risk Factors and Vitamin D Deficiency.

Author keywords: Cardiovascular co-morbidity, Rheumatoid Arthritis and Vitamin D metabolites.

What This Means in Plain Language

The paper is a randomized study of Vitamin D, K2, Magnesium and Zinc in 160 patients in people with rheumatoid arthritis.

The publication is from 2017 (BMJ open), a journal based in England.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, Rheumatoid arthritis research.