Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health

Multiple Sclerosis, Relapsing-remitting Clinical Trial

Official title:

Pharmacodynamic and Immunologic Effects of Vitamin D Supplementation in Patients With Multiple Sclerosis and Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667796
• Other study ID #: NA_00049428
• Secondary ID: FG-1507-05231
• Status: Completed
• Phase: N/A
• Start date: November 2010
• Est. completion date: March 2014

Study information

• Verified date: March 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Dietary Supplement:
• Vitamin D3

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of California, San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	National Multiple Sclerosis Society, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Serum Level of 25-hydroxyvitamin D	Generalized estimating equations (GEE) with an autoregressive with lag one correlation matrix were used to compare the serially-measured serum 25(OH)D levels between MS patients and Healthy Controls (HCs) to take into account repeated measures and within-subject correlations.	Baseline to 90 days
Secondary	Change in Percentages of T Cell Subsets (IFN?+ and IL-17+)	Analyzed the mean percentage change in IFN?+ and IL-17+ cluster of differentiation 4 (CD4) + cells (post- versus pre- supplementation). This represents a change between two time points (90 days versus baseline).	Baseline, 90 days
Secondary	Gene Expression Microarray	We had initially planned to do whole blood gene expression. The experience gained by the laboratory that was to perform this since the original trial was planned was that this measure is too noisy and would not yield meaningful results. Thus, this analysis will no longer be conducted.	90 days
Secondary	Change in Cytokine Levels	The original plan had been to measure the change in basic serum cytokine levels (e.g. IL-17, interferon gamma; IL-10; pg/microliter). However, due to emerging data suggesting low utility of these measures, this plan was abandoned.	90 days
Secondary	Change in Percentage of B Cells	The change in percentage (day 90-baseline) was originally planned for study. Due to the limited number of patients with samples this plan was abandoned.	90 days