Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01667796
• Date of registration: 13/08/2012
• Prospective Registration: No
• Primary sponsor: Johns Hopkins University
• Public title: Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health
• Scientific title: Pharmacodynamic and Immunologic Effects of Vitamin D Supplementation in Patients With Multiple Sclerosis and Healthy Controls
• Date of first enrolment: November 2010
• Target sample size: 57
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01667796
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Ellen M Mowry, MD, MCR
• Affiliation: Johns Hopkins University

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-remitting

Intervention(s)

Dietary Supplement: Vitamin D3

Primary Outcome(s)

Change in Mean Serum Level of 25-hydroxyvitamin D [Time Frame: Baseline to 90 days]

Secondary Outcome(s)

Change in Cytokine Levels [Time Frame: 90 days]

Gene Expression Microarray [Time Frame: 90 days]

Change in Percentage of B Cells [Time Frame: 90 days]

Change in Percentages of T Cell Subsets (IFN?+ and IL-17+) [Time Frame: Baseline, 90 days]

Secondary ID(s)

FG-1507-05231

NA_00049428

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Multiple Sclerosis Society

University of California, San Francisco

Results

• Results available: Yes
• Date Posted: 01/02/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01667796