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Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis, Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo sugar pill
Ergocalciferol
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Vitamin D deficiency, Disability

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo group

Ergocalciferol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Disease Activity Score (DAS) 28
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).

Secondary Outcome Measures

Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF)
In each dimension and component of AIMS2-SF, item scores are from 0 to 10 with 10 being worst health.

Full Information

First Posted
August 29, 2011
Last Updated
January 27, 2017
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01426347
Brief Title
Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis
Official Title
Vitamin Therapy in Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Vitamin D Deficiency
Keywords
Rheumatoid Arthritis, Vitamin D deficiency, Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Ergocalciferol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo sugar pill
Other Intervention Name(s)
Placebo
Intervention Description
Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.
Intervention Type
Drug
Intervention Name(s)
Ergocalciferol
Other Intervention Name(s)
Vitamin D
Intervention Description
Ergocalciferol 50,000 IU per week for 16 weeks
Primary Outcome Measure Information:
Title
Disease Activity Score (DAS) 28
Description
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).
Time Frame
Baseline and 16 weeks (end of Randomized Controlled Trial (RCT))
Secondary Outcome Measure Information:
Title
Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF)
Description
In each dimension and component of AIMS2-SF, item scores are from 0 to 10 with 10 being worst health.
Time Frame
Baseline and 16 weeks (end of RCT)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uzma J Haque, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

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