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

Study start date: November 1, 2010

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)