N/A
Completed N=57
Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health
Multiple Sclerosis, Relapsing-remitting
Source: ClinicalTrials.gov NCT01667796 ↗
Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Change in Mean Serum Level of 25-hydroxyvitamin D — 65.9; 82.4 nmol/L — p=0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Serum Level of 25-hydroxyvitamin D |
65.9; 82.4 | 0.001 sig |
| SECONDARY Change in Percentages of T Cell Subsets (IFNγ+ and IL-17+) |
-5.2; -13.2; 0.21; -0.17 | — |
| SECONDARY Gene Expression Microarray |
— | — |
| SECONDARY Change in Cytokine Levels |
— | — |
| SECONDARY Change in Percentage of B Cells |
— | — |
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)
Data sourced from ClinicalTrials.gov (NCT01667796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.