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Trial record 1 of 55 for:    vitamin D and multiple sclerosis
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Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT01024777
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : February 6, 2013
Sponsor:
Information provided by (Responsible Party):
Peter A. Calabresi, Johns Hopkins University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Vitamin D Deficiency Drug: Cholecalciferol Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess the Relative Safety and Immunology Effects of Low Dose Versus High Dose Cholecalciferol Supplementation in Patients With Multiple Sclerosis
Study Start Date : March 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: High dose cholecalciferol
Patients in the high dose arm will receive 10,000 international units of cholecalciferol daily.
 Drug: Cholecalciferol
Cholecalciferol (Vitamin D3) 10,000 IU in tablet form will be taken once daily for the duration of the trial (6 months)
Other Name: Vitamin D3
Active Comparator: Low dose cholecalciferol
Patients enrolled in the low dose arm will receive up to 1000 international units of cholecalciferol daily.
 Drug: Cholecalciferol
Cholecalciferol (Vitamin D3) 400 IU in tablet form will be taken once daily for the duration of the trial (6 months)
Other Name: Vitamin D3


Outcome Measures
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Primary Outcome Measures :
  1. Assess safety of high dose cholecalciferol in patients with multiple sclerosis [ Time Frame: 3-6 months ]
  2. Assess the effects of cholecalciferol supplementation on serum immune markers in patients with multiple sclerosis [ Time Frame: 3-6 months ]

Secondary Outcome Measures :
  1. Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024777


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Peter Calabresi, MD Johns Hopkins University
Principal Investigator: John Ratchford, MD Johns Hopkins University
More Information
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Responsible Party: Peter A. Calabresi, Professor of Neurology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01024777    
Other Study ID Numbers: NA_00023005
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: February 6, 2013
Last Verified: February 2013
Keywords provided by Peter A. Calabresi, Johns Hopkins University:
cholecalciferol
multiple sclerosis
vitamin D
D3
Additional relevant MeSH terms:
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Multiple Sclerosis
Vitamin D Deficiency
Sclerosis
Vitamin D
Cholecalciferol
Vitamins
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents