NCT00867217

Vitamin D3 for Aromatase Inhibitor Induced Arthralgias

A Randomized Trial to Evaluate the Benefit of High Dose Vitamin D3 on Aromatase Inhibitor Letrozole-Associated Musculoskeletal Symptoms and Fatigue (The VITAL Trial).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Qamar Khan · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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,

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High Dose Vitamin D	High Dose Vitamin D3 (3 capsules of 10,000 IU) weekly for 24 weeks.
DIETARY_SUPPLEMENT	Placebo	Placebo comparator
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-03-23
• Last updated: 2018-02-09
• Results posted: 2018-02-09

Locations

2 sites across 1 country: United States