Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00279461
Status:
WITHDRAWN
Last Update Posted:
2015-08-04
First Post:
2006-01-17
Brief Title:
Vitamin D Deficiency Causes Immune Dysfunction and Enables or Perpetuates the Development of Rheumatoid Arthritis
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Vitamin D Deficiency Causes Immune Dysfunction and Enables or Perpetuates the Development of Rheumatoid Arthritis Clinical Trial and Investigations on Dendritic Cells
Status:
WITHDRAWN
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Dr Levy terminated from IU in December 2009 Indiana University has no record that this study was initiated prior to his termination
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recent studies have demonstrated that subjects with low blood levels of vitamin D are at a higher risk of developing autoimmune diseases such as Rheumatoid Arthritis RA We are pursuing these studies to test the hypothesis that restoration of vitamin D levels ameliorates the manifestations of RA We will test this hypothesis by inviting patients with RA to participate in a trial that examines the effects of oral vitamin D administration on the clinical expression of this disease For this purpose the participants of this trial will be asked to take an oral dose of 2000 units of vitamin D daily for 6 months We will examine the participants joints assess disease activity measures and determine hisher blood levels of vitamin D before starting this treatment and periodically thereafter
Detailed Description:
Rationale Low vitamin D levels hinders the ability of the macrophage to produce activated 1-25Dihydroxyvitamin at sites of inflammation 1-25Dihydroxyvitamin D has important immunoregulatory functions including down-regulation of antigen-presenting cells such as dendritic cells Under the influence of 1-25Dihydroxyvitamin D these dendritic cells become tolerogenic - as opposed to immunogenic - and abrogate an immune response at early stages Immunogenic dendritic cells play a key role in the development of autoimmune diseases such as Rheumatoid Arthritis RA by presenting self-antigens to the immune system Vitamin D levels are frequently low in patients with RA Restoring vitamin D availability to normal levels in patients with RA may induce improvement of disease manifestations through expansion of the tolerogenic dendritic cell subset
Key Objectives
Conduct a double-blind randomized clinical trial to test the hypothesis that vitamin D administered to patients with active RA has beneficial effects on this disease
Determine if vitamin D administered to patients with RA induces expansion of the tolerogenic dendritic cell subset by analyzing patterns of cell surface marker expression on dendritic cells at different time points during the clinical trial translational studies
Study Population We will recruit early RA patients not more that 12 month duration of diseasewith active joint inflammation cared for at this institutionParticipants must be subjects with active RA at the time of inclusion who are 18 years of age or older and have no history of other autoimmune disorders or other disorders such as cancer or osteoporosis which are also linked to vitamin D deficiency The eligible patients with active RA should be on treatment for RA with Methotrexate at the time of inclusion Patients taking anti-cytokine treatments considered not standard would be excluded Other exclusions include hypercalcemia and a history of renal failure or renal stones
20-25 participants will be allocated to the Vitamin D Group Arm A 20-25 participants will be allocated to Placebo Group Arm B Allocation will be conducted in a randomized double-blind fashion
Summary of Procedures After signing a written consent all potential candidates will undergo a screening interview with the PI and screening blood tests a blood sample of 20 ml is required
RA subjects who qualify to receive the study treatment will be randomized to receive oral vitamin D 2000 units or placebo daily for 6 months Patients will be examined on a monthly basis and will be drawn a 20 ml blood sample every 2 months for monitoring purposes for a period of 12 month The participants within the clinical trial who also participate in the translational studies on dendritic cells will be drawn an additional blood sample of 40 ml on the first month and at the end of the study to isolate their blood dendritic cells We will study the expression of different activation markers on dendritic cells from consenting participants using various immunologic techniques This will allow us to identify and quantify the tolerogenic dendritic cells
Key Objectives
Conduct a double-blind randomized clinical trial to test the hypothesis that vitamin D administered to patients with active RA has beneficial effects on this disease
Determine if vitamin D administered to patients with RA induces expansion of the tolerogenic dendritic cell subset by analyzing patterns of cell surface marker expression on dendritic cells at different time points during the clinical trial translational studies
Study Population We will recruit early RA patients not more that 12 month duration of diseasewith active joint inflammation cared for at this institutionParticipants must be subjects with active RA at the time of inclusion who are 18 years of age or older and have no history of other autoimmune disorders or other disorders such as cancer or osteoporosis which are also linked to vitamin D deficiency The eligible patients with active RA should be on treatment for RA with Methotrexate at the time of inclusion Patients taking anti-cytokine treatments considered not standard would be excluded Other exclusions include hypercalcemia and a history of renal failure or renal stones
20-25 participants will be allocated to the Vitamin D Group Arm A 20-25 participants will be allocated to Placebo Group Arm B Allocation will be conducted in a randomized double-blind fashion
Summary of Procedures After signing a written consent all potential candidates will undergo a screening interview with the PI and screening blood tests a blood sample of 20 ml is required
RA subjects who qualify to receive the study treatment will be randomized to receive oral vitamin D 2000 units or placebo daily for 6 months Patients will be examined on a monthly basis and will be drawn a 20 ml blood sample every 2 months for monitoring purposes for a period of 12 month The participants within the clinical trial who also participate in the translational studies on dendritic cells will be drawn an additional blood sample of 40 ml on the first month and at the end of the study to isolate their blood dendritic cells We will study the expression of different activation markers on dendritic cells from consenting participants using various immunologic techniques This will allow us to identify and quantify the tolerogenic dendritic cells
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| No secondary ID at this time | None | None | None |