At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 160 enrolled
Drug / intervention
Letrozole 2.5mg +3 moredrug
Likely dose
Letrozole 2.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Trial to Evaluate the Benefit of High Dose Vitamin D3 on Aromatase Inhibitor Letrozole-Associated Musculoskeletal Symptoms and Fatigue (The VITAL Trial).
In Brief
A Phase 2 clinical trial evaluating High Dose Vitamin D, Placebo, and 2 other interventions for Breast Cancer. Completed, enrolled 160 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsNovartis Pharmaceuticals, BTR Group
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
First PostedMar 2009
Primary CompletionJan 2011
TodayJul 2026
First PostedMar 23, 2009
Enrollment StartMar 1, 2009
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.3 years ago
Interventions
High Dose Vitamin Ddietary
High Dose Vitamin D3 (3 capsules of 10,000 IU) weekly for 24 weeks.
Placebodietary
Placebo comparator
Standard Dose Vitamin D3dietary
Standard Dose Vitamin D3 (600 IU of vitamin D3 daily)
Letrozole 2.5mgdrug
All subjects received letrozole as standard of care.