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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo sugar pill | Drug | Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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)) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 16 weeks (end of RCT) |
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Inclusion Criteria:
Exclusion Criteria:
such as Lupus, Scleroderma, Myositis, Sjogren's Syndrome, Vasculitis'
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| Name | Affiliation | Role |
|---|---|---|
| Uzma J Haque, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
One hundred thirty-nine (139) participants were enrolled for visit 1, and blood was drawn to determine vitamin D levels. Eighty-three (83) were vitamin D deficient by criteria, vitamin D < 30 nanogram/milliliter (ng/ml), and entered the randomized controlled trial. The remaining 56 exited the study because they were vitamin D sufficient.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Group | Rheumatoid Arthritis (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. Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule. |
| FG001 | 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. Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | composite score | Baseline and 16 weeks (end of Randomized Controlled Trial (RCT)) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Uzma Jalal Haque | Johns Hopkins University | 410-550-0578 | uhaque@jhmi.edu |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D004872 | Ergocalciferols |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Ergocalciferol | Drug | Ergocalciferol 50,000 IU per week for 16 weeks |
|
|
| Withdrawal by Subject |
|
| BG001 | 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. Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG001 | 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. Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks |
|
|
| Secondary | 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. | For placebo, analysis is based on 26 at baseline and 33 at the end of RCT For treatment, analysis is based on 27 at baseline and 38 at the end of RCT | Posted | Mean | Standard Deviation | units on a scale | Baseline and 16 weeks (end of RCT) |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | 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. Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks | 0 | 42 | 0 | 42 |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |