Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health
Pharmacodynamic and Immunologic Effects of Vitamin D Supplementation in Patients With Multiple Sclerosis and Healthy Controls
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Change in Mean Serum Level of 25-hydroxyvitamin D | 0.001 | ||
| Change in Mean Serum Level of 25-hydroxyvitamin D | 0.008 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Cholecalciferol
Vitamin D receptor agonist
Results by group
Change in Mean Serum Level of 25-hydroxyvitamin D
Baseline to 90 days
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| MS Subjects | 65.9 nmol/L | 5.9 (Standard Deviation) | 24 |
| Healthy Controls | 82.4 nmol/L | 5.2 (Standard Deviation) | 29 |
MS Subjects
Healthy Controls
p = 0.001
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| MS Subjects | 27 | 0 (0.0%) | |
| Healthy Controls | 30 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change in Mean Serum Level of 25-hydroxyvitamin D
Baseline to 90 days
Other measures (4)
Change in Percentages of T Cell Subsets (IFNγ+ and IL-17+)
Baseline, 90 days
Immune responseGene Expression Microarray
90 days
Immune responseChange in Cytokine Levels
90 days
Immune responseChange in Percentage of B Cells
90 days
Immune response
Who could take part
Relapsing MS · 18 to 60
Show the full criteria
Inclusion criteria
* Female * Healthy or multiple sclerosis * Aged 18 to 60 * Body mass index is between 18 kg/m2 and 30 kg/m2 * Screening 25-hydroxyvitamin D level ≤ 75 nmol/L (30 ng/mL) * White race * Non-Hispanic ethnicity * Willing to use birth control during study * Willing to not use tanning bed during study If subject has multiple sclerosis: * Relapsing-remitting MS, as defined by McDonald 2005 criteria * Screening Expanded Disability Status Scale score ≤ 3.0 * Using no medication for MS, or taking Copaxone, (glatiramer acetate), interferons, or natalizumab
Exclusion criteria
* Pregnant or nursing * Taking multivitamin \& unwilling to remain off it during study * Taking cod liver oil \& unwilling to remain off it during study * On a fat-restricted diet * History of renal disease or nephrolithiasis (kidney stones) * History of liver disease * Taking thiazide diuretics * History of hyperthyroidism * History of infection with Mycobacterium species * History of sarcoidosis * History of cancer * History of cardiac disease * History of HIV * History of gastrointestinal disorder * Taking medications that interfere with gastrointestinal absorption * Cigarette smoker in past month * Use of illicit drugs in past month * Use of steroids in past month * History of hypercalcemia, and screening serum calcium ≤ 10 mg/dL (UCSF) or ≤ 10.7 mg/dL (Johns Hopkins) * History of hypercalciuria * Evidence of anemia (Hgb \<11.0 g/dL) * History of other serious medical conditions * Taking medications that involve the P450 system or may interact with vitamin D (digoxin, diltiazem, verapamil, cimetidine, heparin, or low-molecular weight heparin) * Other concerns about safety from the perspective of the treating physician If subject has MS: -History of major heat sensitivity (leading to sun-avoidant behaviors)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a pilot study of oral vitamin D supplementation to determine if patients with Multiple Sclerosis (MS) and healthy individuals attain a similar increase in serum 25-hydroxyvitamin D levels. The investigators will also assess whether the immunologic or relevant gene expression response to oral vitamin D supplementation differs in patients with MS and healthy controls.
Papers
Results
Metabolic alterations in multiple sclerosis and the impact of vitamin D supplementation.JCI Insight · 2017
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History
Started
Nov 2010
Main results due
Mar 2014
Finished
Mar 2014
Results posted
Feb 2016