Vitamin D Supplementation on Outcome and Disease Activity.

January 3, 2025 updated by: Rajavithi Hospital

Vitamin D Supplementation on Outcome and Disease Activity in Rheumatoid Arthritis Patients At Rajavithi Hospital : a Randomized Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Rajavithi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vitamin D supplementation group
First arm ; add on vitamin D 40,000 IU/week for 12 weeks
Drug: Vitamin D 2
Randomized allocation first arm : add on vitamin D supplementation 40,000 iu/week for 12 weeks
Experimental: second arm
add on placebo
Drug: Placebo
Second arm : add on placebo for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To study efficacy of vitamin D on disease activity RA patients at Rajavithi hospital
Time Frame: 12 weeks
Determine disease activity by DAS28-ESR in relation with vitamin D supplementation.
12 weeks
To study efficacy of vitamin D on IL-6 in RA patients at Rajavithi hospital
Time Frame: 12 weeks
DAS-28 ESR measure from swollen joint count, tender joint count, ESR and patient global assessment
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajavithi Hospital

Investigators

  • Study Chair: Sirilak Nunthiyakul, Medicine, Rajavithi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

May 15, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 31, 2021

First Posted (Actual)

June 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 3, 2025

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 64012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESR

Clinical Trials on Vitamin D 2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe