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The purpose of this study is to determine the safety and the immunologic effects of supplementation with low-dose and high-dose cholecalciferol (vitamin D3) in patients with multiple sclerosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose cholecalciferol | Active Comparator | Patients in the high dose arm will receive 10,000 international units of cholecalciferol daily. |
|
| Low dose cholecalciferol | Active Comparator | Patients enrolled in the low dose arm will receive up to 1000 international units of cholecalciferol daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | Cholecalciferol (Vitamin D3) 10,000 IU in tablet form will be taken once daily for the duration of the trial (6 months) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess safety of high dose cholecalciferol in patients with multiple sclerosis | 3-6 months | |
| Assess the effects of cholecalciferol supplementation on serum immune markers in patients with multiple sclerosis | 3-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Calabresi, MD | Johns Hopkins University | Principal Investigator |
| John Ratchford, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D014808 | Vitamin D Deficiency |
| 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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| Cholecalciferol | Drug | Cholecalciferol (Vitamin D3) 400 IU in tablet form will be taken once daily for the duration of the trial (6 months) |
|
|
| 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 |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |