Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Johns Hopkins University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Johns Hopkins University
Information provided by (Responsible Party):
Uzma Haque, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01426347
First received: August 29, 2011
Last updated: August 30, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Rheumatoid Arthritis Vitamin D Deficiency |
Drug: Placebo sugar pill Drug: Ergocalciferol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Vitamin Therapy in Rheumatoid Arthritis |
Resource links provided by NLM:
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- AIMS-SF [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Disease Activity Score 28 [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 140 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: Placebo
|
|
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 Name: Vitamin D
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Rheumatoid Arthritis diagnosed according to ACR criteria
- ages 18-75
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 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426347
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426347
Locations
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21224 | |
Sponsors and Collaborators
Johns Hopkins University
Investigators
| Principal Investigator: | Uzma J Haque, M.D. | Johns Hopkins University |
More Information
| Responsible Party: | Uzma Haque, Assistant Professor of Medicine, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT01426347 History of Changes |
| Other Study ID Numbers: | VDRA |
| Study First Received: | August 29, 2011 |
| Last Updated: | August 30, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
Rheumatoid Arthritis Vitamin D deficiency Disability |
Additional relevant MeSH terms:
|
Arthritis, Rheumatoid Arthritis Vitamin D Deficiency Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Avitaminosis |
Deficiency Diseases Malnutrition Nutrition Disorders Vitamins Vitamin D Ergocalciferols Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on September 26, 2016