Clinical trial NCT01667796: Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health
Official title: Pharmacodynamic and Immunologic Effects of Vitamin D Supplementation in Patients With Multiple Sclerosis and Healthy Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-remitting
Keywords: Multiple sclerosis
Healthy controls
Pharmacokinetics
Vitamin D
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: National Multiple Sclerosis Society
First posted: 2012-08-17
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: Change in Mean Serum Level of 25-hydroxyvitamin D
timeFrame: Baseline to 90 days
Secondary outcomes:
measure: Change in Percentages of T Cell Subsets (IFNγ+ and IL-17+)
timeFrame: Baseline, 90 days
measure: Gene Expression Microarray
timeFrame: 90 days
measure: Change in Cytokine Levels
timeFrame: 90 days
measure: Change in Percentage of B Cells
timeFrame: 90 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ellen M Mowry, MD, MCR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bhargava P, Fitzgerald KC, Calabresi PA, Mowry EM. Metabolic alterations in multiple sclerosis and the impact of vitamin D supplementation. JCI Insight. 2017 Oct 5;2(19):e95302. doi: 10.1172/jci.insight.95302.