Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple Sclerosis
NCT ID: NCT01024777
Last Updated: 2013-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2010-03-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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High dose cholecalciferol
Patients in the high dose arm will receive 10,000 international units of cholecalciferol daily.
Cholecalciferol
Cholecalciferol (Vitamin D3) 10,000 IU in tablet form will be taken once daily for the duration of the trial (6 months)
Low dose cholecalciferol
Patients enrolled in the low dose arm will receive up to 1000 international units of cholecalciferol daily.
Cholecalciferol
Cholecalciferol (Vitamin D3) 400 IU in tablet form will be taken once daily for the duration of the trial (6 months)
Interventions
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Cholecalciferol
Cholecalciferol (Vitamin D3) 10,000 IU in tablet form will be taken once daily for the duration of the trial (6 months)
Cholecalciferol
Cholecalciferol (Vitamin D3) 400 IU in tablet form will be taken once daily for the duration of the trial (6 months)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Peter A. Calabresi
Professor of Neurology
Principal Investigators
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Peter Calabresi, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
John Ratchford, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
Countries
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Other Identifiers
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NA_00023005
Identifier Type: -
Identifier Source: org_study_id
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