Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter A. Calabresi, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01024777
First received: December 2, 2009
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Multiple Sclerosis
Vitamin D Deficiency
Drug: Cholecalciferol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Assess safety of high dose cholecalciferol in patients with multiple sclerosis [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • Assess the effects of cholecalciferol supplementation on serum immune markers in patients with multiple sclerosis [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024777

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Peter Calabresi, MD Johns Hopkins University
Principal Investigator: John Ratchford, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Peter A. Calabresi, Professor of Neurology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01024777     History of Changes
Other Study ID Numbers: NA_00023005
Study First Received: December 2, 2009
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
cholecalciferol
multiple sclerosis
vitamin D
D3

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Vitamin D Deficiency
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 24, 2014