Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

NCT01426347 | Completed Results

• 1 other identifier: VDRA
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Vitamin D Deficiency

Keywords

Rheumatoid Arthritis; Vitamin D deficiency; Disability

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and 16 weeks (end of Randomized Controlled Trial (RCT))

Secondary Outcomes (1)

• Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF)

  Baseline and 16 weeks (end of RCT)

Study Arms (2)

placebo group

PLACEBO COMPARATOR

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; Drug: Ergocalciferol

Ergocalciferol

ACTIVE COMPARATOR

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

Interventions

Placebo sugar pill DRUG

Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.

Also known as: Placebo

placebo group

Ergocalciferol DRUG

Ergocalciferol 50,000 IU per week for 16 weeks

Also known as: Vitamin D

Ergocalciferol; placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Vitamin D Deficiency

Interventions

Ergocalciferols; Vitamin D

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Uzma Jalal Haque
• Organization: Johns Hopkins University

uhaque@jhmi.edu

410-550-0578

Study Officials

• Uzma J Haque, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2011
• First Posted: August 31, 2011
• Study Start: January 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 20, 2017
• Results First Posted: March 20, 2017

Record last verified: 2017-01

Locations

US (1)