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

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study to Assess the Relative Safety and Immunology Effects of Low Dose Versus High Dose Cholecalciferol Supplementation in Patients With Multiple Sclerosis

Conditions
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Multiple Sclerosis, Vitamin D Deficiency

Intervention / Treatment
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* Drug: Cholecalciferol
* Drug: Cholecalciferol


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High dose cholecalciferol<br>Patients in the high dose arm will receive 10,000 international units of cholecalciferol daily. | Drug: Cholecalciferol<br>* Cholecalciferol (Vitamin D3) 10,000 IU in tablet form will be taken once daily for the duration of the trial (6 months)<br>* Other names: Vitamin D3;|
| Active Comparator: Low dose cholecalciferol<br>Patients enrolled in the low dose arm will receive up to 1000 international units of cholecalciferol daily. | Drug: Cholecalciferol<br>* Cholecalciferol (Vitamin D3) 400 IU in tablet form will be taken once daily for the duration of the trial (6 months)<br>* Other names: Vitamin D3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess safety of high dose cholecalciferol in patients with multiple sclerosis |  | 3-6 months | 
| Assess the effects of cholecalciferol supplementation on serum immune markers in patients with multiple sclerosis |  | 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholecalciferol, multiple sclerosis, vitamin D, D3