Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

January 27, 2017 updated by: Johns Hopkins University

Vitamin Therapy in Rheumatoid Arthritis

The purpose of this study is to investigate the effect of vitamin D repletion on disease activity and disability in patients with rheumatoid arthritis.

The investigators hypothesize that rheumatoid arthritis (RA) patients with vitamin D deficiency have greater disease activity and disability, compared to RA patients with normal vitamin D levels. The investigators also hypothesize that vitamin D treatment in these deficient patients will result in a decrease in RA disease activity and disability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

139

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

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University

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 to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Rheumatoid Arthritis diagnosed according to American College of Rheumatology (ACR) criteria
  • ages 18-75 years

Exclusion Criteria:

  • Diagnosis of any other autoimmune disease:

such as Lupus, Scleroderma, Myositis, Sjogren's Syndrome, Vasculitis'

  • Having any of the following conditions with in the last 6 months Hypercalcemia, Hyperparathyroidism, Active tuberculosis (TB), Lymphoma or any other type of cancer, Sarcoidosis, Seizure, Stroke
  • Severe heart problems
  • Kidney failure requiring dialysis treatment
  • Liver failure or cirrhosis of the liver
  • Poorly controlled hypertension
  • current uncontrolled Depression, Bipolar Disorder, or other Psychiatric illness
  • Pregnancy

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: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo group

RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.

Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.
Drug: Placebo sugar pill
Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.
Other Names:
  • Placebo
Drug: Ergocalciferol
Ergocalciferol 50,000 IU per week for 16 weeks
Other Names:
  • Vitamin D
ACTIVE_COMPARATOR: Ergocalciferol
Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.
Drug: Ergocalciferol
Ergocalciferol 50,000 IU per week for 16 weeks
Other Names:
  • Vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Activity Score (DAS) 28
Time Frame: Baseline and 16 weeks (end of Randomized Controlled Trial (RCT))

We measured disease activity as measured by DAS 28 at baseline and at the completion of Randomized Controlled trial, both in the placebo and the active treatment group.

We used DAS-28 scores to indicate disease activity. The DAS -28 scale has a minimum of 0 and a maximum of 10, with higher numbers indicating higher disease activity.

We used the following cut-offs: Remission (< 2.6), low disease activity (< 3.2), moderate disease activity (< 5.1) and high disease activity (> 5.1).
Baseline and 16 weeks (end of Randomized Controlled Trial (RCT))

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF)
Time Frame: Baseline and 16 weeks (end of RCT)
In each dimension and component of AIMS2-SF, item scores are from 0 to 10 with 10 being worst health.
Baseline and 16 weeks (end of RCT)

Collaborators and Investigators

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

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Uzma J Haque, M.D., Johns Hopkins University

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

January 1, 2009

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

August 29, 2011

First Submitted That Met QC Criteria

August 30, 2011

First Posted (ESTIMATE)

August 31, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2017

Last Update Submitted That Met QC Criteria

January 27, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VDRA

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.

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