Clinical trial · Interventional
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).
NCT00867217CI-TRIAL-00031622VITALcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Dose Vitamin D | Dietary Supplement | — | UNRESOLVED |
| Letrozole 2.5mg | Drug | Letrozole | ALIAS |
| Placebo | Dietary Supplement | — | UNRESOLVED |
| Standard Dose Vitamin D3 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High Dose Vitamin D
- description
- High Dose Vitamin D3 capsule (3 x 10,000 IU capsules weekly). All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily).
- interventionNames
- Dietary Supplement: High Dose Vitamin D
- Dietary Supplement: Standard Dose Vitamin D3
- Drug: Letrozole 2.5mg
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo matched for High Dose Vitamin D3 capsules. All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily).
- interventionNames
- Dietary Supplement: Placebo
- Dietary Supplement: Standard Dose Vitamin D3
- Drug: Letrozole 2.5mg
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.