Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESR
Conditions
Brief summary
To study efficacy of Vitamin D on outcome and disease activity ; DAS28-ESR in Rheumatoid arthritis patients at Rajavithi hospital .
Interventions
DRUGVitamin D 2
Randomized allocation first arm : add on vitamin D supplementation 40,000 iu/week for 12 weeks
DRUGPlacebo
Second arm : add on placebo for 12 weeks
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age \> 18 yrs old * RA diagnosed by ACR/EULAR 2010 * low to moderate disease activity * on stable NSAIDs and DMARDs for at least 1 month * Received Prednisolone less than or equal to 7.5 mg/day * serum calcium, phosphorus and ALP are within normal limit.
Exclusion criteria
* Chronic kidney disease stage 3 or higher * History of TB * History of Chronic liver disease * Pregnancy or breast-feeding * adjustment of immuno-suppressive drugs, steroid * other connective tissue disease * Vitamin D allergy * received other drugs which have vitamin D component * serum Vitamin D less than 10 ng/mL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To study efficacy of vitamin D on disease activity RA patients at Rajavithi hospital | 12 weeks | Determine disease activity by DAS28-ESR in relation with vitamin D supplementation. |
| To study efficacy of vitamin D on IL-6 in RA patients at Rajavithi hospital | 12 weeks | DAS-28 ESR measure from swollen joint count, tender joint count, ESR and patient global assessment |
Countries
Thailand
Outcome results
None listed