Vitamine D in Multiple Sclerosis
Randomised Double Blind Placebo-controlled Trial of Vitamine D Supplement in Multiple Sclerosis
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Ergocalciferol
Vitamin D receptor agonist
Placebo
- Placebo
What it measured
Main measures
Expanded disability state scale score (EDSS)
Changes in EDSS from baseline to 6 months
Disability progression
Other measures (1)
Annual relapse rate(ARR)
Changes in ARR from baseline to 12 months
Relapses
Who could take part
Relapsing MS · 18 to 50
Show the full criteria
Inclusion criteria
* BMI:18-30kg/m2 * caucasian race * Relapsing remitting multiple sclerosis * treatment with interferon beta
Exclusion criteria
* Recent vitamin D supplement therapy * Restricted fat diet * nephrolithiasis in recent 5 years * Past history of hyperparathyroidism, sarcoidosis, cancer * Past history of hepatic disease * Past history of gastrointestinal disease * Past history of mycobacterial infection * Past history of hypercalcemia and hypercalciuria * serum creatinine>1.5 * Smoking, drug abuse and corticosteroid therapy in recent year * treatment with thiazides or other drugs that inhibit vitamin D absorption * Disease attack in recent 2 months * Serum Ca>2.6mm0l/L * Serum 25(OH)D>85mmol/L * hypersensitivity to cholecalciferol * Past history of heart disease * Major depression * Uncontrolled hypertension (BP>180/110) * Immunosuppressive therapy
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Two hundred and forty patients with multiple sclerosis who met the study criteria will be enrolled in this randomized double blind placebo-controlled clinical trial. They will randomly assigned to placebo or vitamin D treatment group. The total time of study is 52 weeks and the vitamin D group will be treated by weekly 50000 International unit(IU) vitamin D, while the other group will receive weekly placebo. The annual relapse rate and EDSS will be compared at baseline, month 6 and 12.
Papers
Loading reviews and guidelines…
Related trials
- Effect of Probiotics on Relapsing-Remitting Multiple Sclerosis
Not a drug-phase study · Completed
No results found
- Targeting the Gut Dysbiosis to Treat Inflammation-driven Synaptopathy
Not a drug-phase study · Status unknown
No results found
- Investigating the Effects of Hydroxyvitamin D3 on Multiple Sclerosis
Phase 4 · Status unknown
No results found
- Efficacy of Diet on Quality of Life in Multiple Sclerosis
Not a drug-phase study · Running, not recruiting
Still running
- Prebiotic vs Probiotic in Multiple Sclerosis
Not a drug-phase study · Completed
Paper found, not read
- Longitudinal Effect of Vitamin D3 Replacement on Cognitive Performance
Not a drug-phase study · Status unknown
No results found
History
Started
Mar 2013
Main results due
Aug 2014
Finished
Oct 2014