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OpenTrials
Completed

NCT Number: NCT01024777

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

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Avitaminosis Deficiency Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Malnutrition Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

Cholecalciferol (Vitamin D3) 10,000 IU in tablet form will be taken once daily for the duration of the trial (6 months)

Other names: Vitamin D3

Primary outcomes

  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 outcomes

  1. Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 3, 2009
Registry last updated
Feb 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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