Rheumatoid ArthritisNCT01426347
Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis
A study testing Ergocalciferol in people with Rheumatoid Arthritis and Vitamin D Deficiency, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis, Vitamin D Deficiency
- What is being tested?
- Ergocalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatoid Arthritis diagnosed according to American College of Rheumatology (ACR) criteria
- ages 18-75 years
Who cannot join
- 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
Show all 9Show fewer
- Poorly controlled hypertension
- current uncontrolled Depression, Bipolar Disorder, or other Psychiatric illness
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin Therapy in Rheumatoid Arthritis
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
- Being tested
- Placebo sugar pill, Ergocalciferol
- Keywords
- Rheumatoid Arthritis, Vitamin D deficiency, Disability
- Medical subject headings
- Arthritis, Rheumatoid, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo sugar pillDrug
Also called Placebo
Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.
ErgocalciferolDrug
Also called Vitamin D
Ergocalciferol 50,000 IU per week for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ergocalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
In each dimension and component of AIMS2-SF, item scores are from 0 to 10 with 10 being worst health.
Measured: Baseline and 16 weeks (end of RCT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startJan 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uzma J Haque, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426347
- Sponsor's protocol ID
- VDRA
- Status last verified
- Jan 2017
- First submitted
- 29 Aug 2011
- Last updated
- 20 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin Therapy in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01426347
- Acronym / sponsor ID
- VDRA
- Conditions
- Rheumatoid Arthritis, Vitamin D Deficiency
- Keywords
- Rheumatoid Arthritis, Vitamin D deficiency, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 31 Aug 2011 (estimated)
- Results
- Posted 20 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Drug: Placebo sugar pill, Drug: ErgocalciferolRA 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 | Drug: ErgocalciferolPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Rheumatoid Arthritis diagnosed according to American College of Rheumatology (ACR) criteria
- ages 18-75 years
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo sugar pillAlso: PlaceboIntervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule. | Drug | placebo group |
| ErgocalciferolAlso: Vitamin DErgocalciferol 50,000 IU per week for 16 weeks | Drug | Ergocalciferol, placebo group |
Primary outcome
Disease Activity Score (DAS) 28
Time frame: 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).
1 secondary outcome
Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF)
Time frame: Baseline and 16 weeks (end of RCT)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uzma J Haque, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergocalciferol in people with Rheumatoid Arthritis and Vitamin D Deficiency, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Activity Score (DAS) 28 (time frame: Baseline and 16 weeks (end of Randomized Controlled Trial (RCT))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.