Vitamin D3 for Aromatase Inhibitor Induced Arthralgias

Breast Cancer Clinical Trial

— VITAL  

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 Details — Status: Completed

Administrative data

• NCT number: NCT00867217
• Other study ID #: 11548
• Status: Completed
• Phase: Phase 2
• First received: March 20, 2009
• Last updated: January 11, 2018
• Start date: March 2009
• Est. completion date: January 2011

Study information

• Verified date: January 2018
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Dietary Supplement:
• High Dose Vitamin D
High Dose Vitamin D3 (3 capsules of 10,000 IU) weekly for 24 weeks.
• Placebo
Placebo comparator
• Standard Dose Vitamin D3
Standard Dose Vitamin D3 (600 IU of vitamin D3 daily)

Drug:
• Letrozole 2.5mg
All subjects received letrozole as standard of care.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Westwood	Kansas
United States	Cancer Centers of Kansas, P.A.	Wichita	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
Qamar Khan	BTR Group, Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Worsening of Musculoskeletal Symptoms (MS)	Worsening of Musculoskeletal Symptoms (MS) is defined as any one of the following three events: (a) an increase by at least 0.25 in the Health Assessment Questionnaire II (HAQ II, a measure of disability from joint pain) score, (b) an increase in patient reported severity of joint and/or muscle pain, or (c) discontinuation from trial prior to 24 weeks specifically because of problems with musculoskeletal symptoms.	Change from Baseline to 24 Weeks