Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3
A Pilot Study to Assess the Relative Safety and Immunology Effects of Low Dose Versus High Dose Cholecalciferol Supplementation in Patients With Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Cholecalciferol
Vitamin D receptor agonist
What it measured
Main measures
Assess safety of high dose cholecalciferol in patients with multiple sclerosis
3-6 months
SafetyAssess the effects of cholecalciferol supplementation on serum immune markers in patients with multiple sclerosis
3-6 months
Other measures (1)
Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis
6 months
Who could take part
Relapsing MS · 18 to 55
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Peripheral T-Cells, B-Cells, and Monocytes from Multiple Sclerosis Patients Supplemented with High-Dose Vitamin D Show Distinct Changes in Gene Expression Profiles.Nutrients · 2022
Results
Safety and immunologic effects of high- vs low-dose cholecalciferol in multiple sclerosis.Neurology · 2016
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History
Started
Mar 2010
Main results due
Jan 2013
Finished
Jan 2013