Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments high dose vitamin d3, placebo
Phase phase 2
Sponsor University of Kansas
Collaborator Novartis Pharmaceuticals
Start date March 2009
End date September 2011
Trial size 160 participants
Trial identifier NCT00867217, 11548

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. 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

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
High Dose Vitamin D3 capsules given weekly along with standard of care medication
high dose vitamin d3 there are none
Drug: High Dose Vitamin D3 High Dose Vitamin D3 (3 capsules of 10,000 IU or placebo) weekly for 24 weeks Arms: Vitamin D
(Placebo Comparator)
Placebo given weekly along with standard of care medication
placebo there are none
Drug: Placebo Placebo comparator Arms: Placebo

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2010.
Information provided to ClinicalTrials.gov by University of Kansas.