A Randomized Trial to Evaluate the Benefit of High Dose Vitamin D3 on Aromatase Inhibitor Letrozole-Associated Musculoskeletal Symptoms and Fatigue (The VITAL Trial).
This protocol will examine the relationship between vitamin D levels (25-hydroxyvitamin D)
and various quality of life measures in women being treated with letrozole as standard care
for early stage breast cancer.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Assessments of musculoskeletal symptoms: Health Assessment Questionnaire II (HAQ II), Joint Pain Score, Brief Pain Inventory (BPI), Brief Fatigue Inventory (BFI)
Qamar J Khan, MD
University of Kansas
United States: Food and Drug Administration
|University of Kansas Medical Center||Kansas City, Kansas 66160-7353|
|Cancer Centers of Kansas, P.A.||Wichita, Kansas 67214|