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| ID | Type | Description | Link |
|---|---|---|---|
| FG-1507-05231 | Other Grant/Funding Number | National Multiple Sclerosis Society |
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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| National Multiple Sclerosis Society | OTHER |
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This is a pilot study of oral vitamin D supplementation to determine if patients with Multiple Sclerosis (MS) and healthy individuals attain a similar increase in serum 25-hydroxyvitamin D levels. The investigators will also assess whether the immunologic or relevant gene expression response to oral vitamin D supplementation differs in patients with MS and healthy controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 | Experimental | Both those with MS and healthy controls will be given vitamin D3 5000 IU/day by mouth for 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Serum Level of 25-hydroxyvitamin D | Generalized estimating equations (GEE) with an autoregressive with lag one correlation matrix were used to compare the serially-measured serum 25(OH)D levels between MS patients and Healthy Controls (HCs) to take into account repeated measures and within-subject correlations. | Baseline to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentages of T Cell Subsets (IFNγ+ and IL-17+) | Analyzed the mean percentage change in IFNγ+ and IL-17+ cluster of differentiation 4 (CD4) + cells (post- versus pre- supplementation). This represents a change between two time points (90 days versus baseline). | Baseline, 90 days |
| Gene Expression Microarray |
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Inclusion Criteria:
If subject has multiple sclerosis:
Exclusion Criteria:
If subject has MS:
-History of major heat sensitivity (leading to sun-avoidant behaviors)
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| Name | Affiliation | Role |
|---|---|---|
| Ellen M Mowry, MD, MCR | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| Johns Hopkins University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28978801 | Derived | Bhargava P, Fitzgerald KC, Calabresi PA, Mowry EM. Metabolic alterations in multiple sclerosis and the impact of vitamin D supplementation. JCI Insight. 2017 Oct 5;2(19):e95302. doi: 10.1172/jci.insight.95302. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Multiple Sclerosis (MS) Subjects | MS patients |
| FG001 | Healthy Controls | Healthy control subjects |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MS Subjects | Female subjects with MS |
| BG001 | Healthy Controls | Female subjects without MS |
| 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 | Change in Mean Serum Level of 25-hydroxyvitamin D | Generalized estimating equations (GEE) with an autoregressive with lag one correlation matrix were used to compare the serially-measured serum 25(OH)D levels between MS patients and Healthy Controls (HCs) to take into account repeated measures and within-subject correlations. | Posted | Mean | Standard Deviation | nmol/L | Baseline to 90 days |
|
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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 | MS Subjects | MS patients |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | A control got palpitations. Cardiac workup: rare premature atrial and ventricular contractions; the person then reported remote atrial fibrillation (not disclosed at screening visit). This was not deemed to be related to vitamin D supplementation. |
The generalizability of the findings of this study (beyond female Caucasians) has to be further tested. It is possible that there were unmeasured confounders influencing results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen Mowry | Johns Hopkins | 4106141522 | vitamindtrialms@jhmi.edu |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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We had initially planned to do whole blood gene expression. The experience gained by the laboratory that was to perform this since the original trial was planned was that this measure is too noisy and would not yield meaningful results. Thus, this analysis will no longer be conducted. |
| 90 days |
| Change in Cytokine Levels | The original plan had been to measure the change in basic serum cytokine levels (e.g. IL-17, interferon gamma; IL-10; pg/microliter). However, due to emerging data suggesting low utility of these measures, this plan was abandoned. | 90 days |
| Change in Percentage of B Cells | The change in percentage (day 90-baseline) was originally planned for study. Due to the limited number of patients with samples this plan was abandoned. | 90 days |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Change in Percentages of T Cell Subsets (IFNγ+ and IL-17+) | Analyzed the mean percentage change in IFNγ+ and IL-17+ cluster of differentiation 4 (CD4) + cells (post- versus pre- supplementation). This represents a change between two time points (90 days versus baseline). | Posted | Mean | Standard Deviation | percentage of cells | Baseline, 90 days |
|
|
|
| Secondary | Gene Expression Microarray | We had initially planned to do whole blood gene expression. The experience gained by the laboratory that was to perform this since the original trial was planned was that this measure is too noisy and would not yield meaningful results. Thus, this analysis will no longer be conducted. | We had initially planned to do whole blood gene expression. The experience gained by the laboratory that was to perform this since the original trial was planned was that this measure is too noisy and would not yield meaningful results. Thus, this analysis will no longer be conducted. | Posted | 90 days |
|
|
| Secondary | Change in Cytokine Levels | The original plan had been to measure the change in basic serum cytokine levels (e.g. IL-17, interferon gamma; IL-10; pg/microliter). However, due to emerging data suggesting low utility of these measures, this plan was abandoned. | Cytokine levels data were not analyzed and are no longer planned to be measured as outcomes. | Posted | 90 days |
|
|
| Secondary | Change in Percentage of B Cells | The change in percentage (day 90-baseline) was originally planned for study. Due to the limited number of patients with samples this plan was abandoned. | B Cell data were not analyzed and are no longer planned to be measured as outcomes. | Posted | 90 days |
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Healthy Controls | Healthy control subjects | 0 | 30 | 1 | 30 |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |