Vitamin D3 for Aromatase Inhibitor Induced Arthralgias
This trial is active, not recruiting.
|Treatments||high dose vitamin d3, placebo|
|Sponsor||University of Kansas|
|Start date||March 2009|
|End date||September 2011|
|Trial size||160 participants|
|Trial identifier||NCT00867217, 11548|
The primary purpose is to determine if high dose vitamin D3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin D levels. The primary hypothesis is that high dose vitamin D3 prevents the worsening of musculoskeletal symptoms when compared to a standard dose vitamin D3 treatment.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Assessments of musculoskeletal symptoms: Health Assessment Questionnaire II (HAQ II), Joint Pain Score, Brief Pain Inventory (BPI), Brief Fatigue Inventory (BFI)
time frame: 24 weeks
Visual analog pain scale; hand grip strength; menopausal Quality of Life (MEN-QOL); serum 25OHD levels; serum letrozole levels; single nucleotide polymorphisms of vitamin D receptor genes
time frame: 6 months
Female participants at least 18 years old.
Inclusion Criteria: - Post-menopausal women newly diagnosed with early stage breast cancer, who would be treated with an aromatase inhibitor - Serum 25OHD levels < 40 ng/ml Exclusion Criteria: - Severe or debilitating musculoskeletal pain - Known metastatic disease - History of renal stones - History of hypercalcemia or hyperthyroidism - Currently receiving adjuvant or neoadjuvant chemotherapy - Currently receiving other investigational agents
|Official title||A Randomized Trial to Evaluate the Benefit of High Dose Vitamin D3 on Aromatase Inhibitor Letrozole-Associated Musculoskeletal Symptoms and Fatigue (The VITAL Trial).|
|Principal investigator||Qamar J Khan, MD|
|Description||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.|
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