Vitamin D Supplementation on Outcome and Disease Activity.
Not Applicable
Completed
- Conditions
- Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESR
- Interventions
- Drug: Placebo
- Registration Number
- NCT04909931
- Lead Sponsor
- Rajavithi Hospital
- Brief Summary
To study efficacy of Vitamin D on outcome and disease activity ; DAS28-ESR in Rheumatoid arthritis patients at Rajavithi hospital .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description second arm Placebo add on placebo vitamin D supplementation group Vitamin D 2 First arm ; add on vitamin D 40,000 IU/week for 12 weeks
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rajavithi hospital
🇹ðŸ‡Bangkok, Thailand