Rheumatoid arthritis Musculoskeletal Diseases Other rheumatoid arthritis
Conditions
Interventions
The participants will be randomised to the following:
Control group: 5 mg of folic acid (oral) once a week as per methotrexate protocol
"Active" group: 5 mg of folic acid (oral) 7 days a week (extra
Sponsors
University of Dundee (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, 18 years old or over 2. Fulfil the 1987 American College of Rheumatology (ACR) classification criteria for RA 3. On methotrexate for at least 6 months
Exclusion criteria
Exclusion criteria: 1. Previous cardiovascular or cerebrovascular events in the last 3 years 2. Undergoing treatment for a cardiovascular risk factor except: 2.1. Patients with hypertension on stable medication for the last 3 months 2.2. Patients with hypercholesterolemia on stable medication for the last 3 months 3. Contraindications to allopurinol (moderate to severe renal impairment, liver impairment, concomitant treatment with azathioprine, known allergy to allopurinol)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endothelial function measured by the following at baseline, 4 and 6 months: 1. Laser Doppler flowmetry after iontophoretic delivery of acetylcholine and sodium nitroprusside (microvascular) 2. Brachial artery flow mediated dilatation (macrovascular) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following were assessed at baseline, 4 and 6 months: 1. Endothelial function measured by blood testing of vascular function and damage (E selectin, thrombomodulin) 2. Arterial stiffness measured by applanation tonometry 3. Oxidative stress (Isoprostane levels) 4. Serum homocysteine, folic acid and uric acid levels 5. RA disease activity (28-item Disease Activity Score [DAS28], Health Assessment Questionnaire [HAQ], the 36-item short form health survey [SF-36]) | — |
Countries
United Kingdom
Outcome results
None listed