Vitamin D Supplementation on Outcome and Disease Activity.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-12-01

Brief Summary

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

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Detailed Description

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Conditions

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Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESR

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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vitamin D supplementation group

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

Group Type EXPERIMENTAL

Vitamin D 2

Intervention Type DRUG

Randomized allocation first arm : add on vitamin D supplementation 40,000 iu/week for 12 weeks

second arm

add on placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Second arm : add on placebo for 12 weeks

Interventions

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Vitamin D 2

Randomized allocation first arm : add on vitamin D supplementation 40,000 iu/week for 12 weeks

Intervention Type DRUG

Placebo

Second arm : add on placebo for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes