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Vitamin D3 for Aromatase Inhibitor Induced Arthralgias — VITAL  

Breast Cancer Clinical Trial

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).

Clinical Trial Summary

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.

Clinical Trial Description

The primary hypothesis is that high dose vitamin D3 plus standard dose vitamin D3 prevents the worsening of musculoskeletal symptoms when compared to a standard dose vitamin D3 treatment. 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. All subjects received letrozole and a standard dose of vitamin D3 (600 IU daily). Randomization was between high dose vitamin D3 (30,000 IU once per week) vs. a blinded, matched placebo, ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00867217
Study type Interventional
Source University of Kansas Medical Center
Contact
Status Completed
Phase Phase 2
Start date March 2009
Completion date January 2011
View Details
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