A Pilot Study to Assess the Relative Safety and Immunology Effects of Low Dose Versus High Dose Cholecalciferol Supplementation in Patients With Multiple Sclerosis
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| City: |
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Baltimore |
| State: |
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Maryland |
| Zip Code: |
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21287 |
| Conditions: |
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Multiple Sclerosis - Vitamin D Deficiency |
| Purpose: |
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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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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Between ages of 18-55 years (inclusive)
- Serum 25(OH) vitamin D levels between 20-50 ng/mL and a candidate for vitamin D
supplementation
- Patients with or without immunomodulatory therapy for RRMS
- Diagnosis of multiple sclerosis
Exclusion Criteria:
- Serum 25(OH) vitamin D deficient level < 20 ng/mL
- High dose vitamin D supplementation in the past 3 months
- Pregnancy
- History of tuberculosis, hyperparathyroidism, sarcoidosis or kidney stones
- Baseline serum creatinine above 1.5
- Hypersensitivity to vitamin D preparations
- Milk allergy
- Unable to consent
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| NCT ID: |
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NCT01024777 |
| Primary Contact: |
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Principal Investigator
Peter Calabresi, MD
Johns Hopkins University
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| Backup Contact: |
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N/A |
| Location Contact: |
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Baltimore, Maryland 21287
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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