Clinical trial · Interventional
High Dose Vitamin D vs Standard Dose Vitamin D Study
A Randomized, Controlled Trial of High Dose vs. Standard Dose Vitamin D for Aromatase-Inhibitor Induced Arthralgia in Breast Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): An interim analysis demonstrated no benefit of high dose vitamin D when compared to standard dose vitamin D in the reduction or prevention of arthralgia
Summary
Brief summary (as posted)
This study is being done to look at the difference, if there is a difference between two different doses of Vitamin D and the reduction of joint/muscle pain (arthralgia)that is caused by taking anti-estrogen medications (aromatase inhibitors) by breast cancer patients. The investigators hope to learn if taking a higher dose of Vitamin D is a good way to prevent aromatase inhibitor arthralgia (AIA).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 50,000 IU Vitamin D supplement | Drug | — | UNRESOLVED |
| 800 IU Vitamin D Supplement | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High Dose Vitamin D ARM
- description
- 50,000 IU Vitamin D supplement
- interventionNames
- Drug: 50,000 IU Vitamin D supplement
- type
- ACTIVE_COMPARATOR
- label
- 800 IU Vitamin D Supplement
- description
- 800 IU Vitamin D Supplement
- interventionNames
- Drug: 800 IU Vitamin D Supplement
Primary outcomes (1)
- measure
- Number of Participants With Aromatase Inhibitor Induced Arthralgia (AIA) After 12 Weeks of Therapy
- timeFrame
- 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All participants must be female and at least 21 years of age * Signed informed consent * Patients must have had histologically confirmed stage I-III breast carcinoma that is positive for Estrogen Receptor (ER) and/or Progesterone Receptor (PR). * Post-menopausal * Beginning adjuvant aromatase inhibitor therapy, with no previous use within the last 6 weeks * Bisphosphonates are allowed at the treating investigator¡¦s discretion * Performance status (WHO/ECOG scale) 0-2. Exclusion Criteria: * History of kidney stones * Hypercalcemia at baseline, defined as any corrected calcium greater than the laboratory's normal parameters * History of either symptomatic hypercalcemia or hyperparathyroidism, at the treating investigator's discretion * Baseline Vitamin D level greater than 50 ng/mL * Inability or unwillingness to comply with, or follow study procedures. * Currently taking Phenytoin or phenobarbital -7 Currently taking cholestyramine or orlistat * Malabsorption syndrome, such as Crohn's disease Prohibited Therapies: Patients may not take additional Calcium and Vitamin D aside from the study medications. Patients who are on cholestyramine or orlistat will not be allowed on the trial. Also, patients who are taking phenytoin or phenobarbital are not allowed on the trial either because of interaction between Vitamin D and anti-epileptic medications.
References
Publications (0)
Data not yet available