Vitamin D Supplementation on Outcome and Disease Activity.

Rajavithi Hospital

Status: Completed

Conditions: Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESR

Treatments: Drug: Vitamin D 2; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04909931

64012

Details and patient eligibility

About

To study efficacy of Vitamin D on outcome and disease activity ; DAS28-ESR in Rheumatoid arthritis patients at Rajavithi hospital .

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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60 participants in 2 patient groups

vitamin D supplementation group

Experimental group

Description:

First arm ; add on vitamin D 40,000 IU/week for 12 weeks

Treatment:

Drug: Vitamin D 2

second arm

Experimental group

Description:

add on placebo

Treatment:

Drug: Placebo