NCT01509079

Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors

Phase 2 Study Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Purpose of this study is to determine whether vitamin D3 supplements will decrease the muscle and bone pain that are reported by women who take Aromatase Inhibitors.

Detailed description

This project will determine the efficacy of vitamin D3 supplements for reducing side effects of treatment with aromatase inhibitors in women with a history of breast cancer that have no evidence of current disease. The aromatase inhibitors (AI) have become a critical component of adjuvant therapy for this population, but they cause bone pain, joint pain, joint stiffness, and muscle weakness in approximately 40% of patients. These symptoms, referred to as aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), decrease quality of life and medication adherence. Identifying effective ways to decrease these symptoms may allow for longer and more adherent medication use and thus may improve disease-free survival. We hypothesize that vitamin D3 may decrease symptoms associated with the use of aromatase inhibitors.

Conditions

• Muscle Pain
• Joint Pain

Interventions

Type	Name	Description
DRUG	Vitamin D3	Cholecalciferol capsule, 4000IU, daily for 6 months
DRUG	Vitamin D3	cholecalciferol capsule, 600 IU, daily for 6 months

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-10-01
• Completion: 2015-03-01
• First posted: 2012-01-12
• Last updated: 2019-06-18
• Results posted: 2016-11-29

Locations

1 site across 1 country: United States