Rheumatoid Arthritis, Vitamin D Deficiency
Conditions
Keywords
Rheumatoid Arthritis, Vitamin D deficiency, Disability
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.
Interventions
Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.
DRUGErgocalciferol
Ergocalciferol 50,000 IU per week for 16 weeks
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Activity Score (DAS) 28 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 41 |
| 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 | 42 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 0 |
Baseline characteristics
| Characteristic | Ergocalciferol | Total | Placebo Group |
|---|---|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 12.2 | 52.5 years STANDARD_DEVIATION 12.8 | 52.7 years STANDARD_DEVIATION 13.5 |
| Race/Ethnicity, Customized Caucasian | 31 participants | 63 participants | 32 participants |
| Race/Ethnicity, Customized Non-caucasian | 11 participants | 20 participants | 9 participants |
| Sex: Female, Male Female | 36 Participants | 69 Participants | 33 Participants |
| Sex: Female, Male Male | 6 Participants | 14 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 41 | 0 / 42 |
| serious Total, serious adverse events | 0 / 41 | 0 / 42 |
Outcome results
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).
Time frame: Baseline and 16 weeks (end of Randomized Controlled Trial (RCT))
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Group | Disease Activity Score (DAS) 28 | Baseline | 3.4 composite score | Standard Deviation 1.5 |
| Placebo Group | Disease Activity Score (DAS) 28 | 16 weeks (end of RCT) | 3.5 composite score | Standard Deviation 1.5 |
| Ergocalciferol | Disease Activity Score (DAS) 28 | Baseline | 2.8 composite score | Standard Deviation 1.3 |
| Ergocalciferol | Disease Activity Score (DAS) 28 | 16 weeks (end of RCT) | 3.1 composite score | Standard Deviation 1.3 |
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.
Time frame: Baseline and 16 weeks (end of RCT)
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Group | Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF) | Baseline | 1.9 units on a scale | Standard Deviation 1.3 |
| Placebo Group | Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF) | 16 weeks (end of RCT) | 1.9 units on a scale | Standard Deviation 1.5 |
| Ergocalciferol | Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF) | Baseline | 1.7 units on a scale | Standard Deviation 1.6 |
| Ergocalciferol | Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF) | 16 weeks (end of RCT) | 1.6 units on a scale | Standard Deviation 2.1 |