Clinical trial · Interventional
Vitamin D and Breast Cancer: Does Weight Make a Difference?
NCT01472445CI-TRIAL-00109184terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
This is a research study of the effect of Vitamin D on breast cancer. We hope to learn whether Vitamin D can change characteristics of certain genes in a breast cancer tumor that affect its growth. We believe some of these characteristics may be influenced by body weight.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vitamin D | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Non-obese (Body Mass Index ≤ 25)
- description
- Non-obese participants receive Vitamin D at 400 or 10,000 IU/day
- interventionNames
- Drug: Vitamin D
- type
- EXPERIMENTAL
- label
- Obese (Body Mass Index > 25)
- description
- Obese participants receive Vitamin D at 400 or 10,000 IU/day
- interventionNames
- Drug: Vitamin D
Primary outcomes (1)
- measure
- Expression Level of Insulin-like Growth Factor-binding Protein 3 (IGFBP-3) Gene
- timeFrame
- up to 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women who have undergone a core needle biopsy demonstrating an operable breast cancer whom have not yet had any further therapy. * No prior therapy for breast cancer. * Age 18 years or older. * Any menopausal status * Planned surgical resection of breast cancer or repeat core biopsy tissue sampling prior to initiation of neoadjuvant systemic chemotherapy. * Availability of tissue blocks from initial core needle biopsy. * Signed informed consent. * Willing to discontinue use of all supplements containing Vitamin D for the duration of the study, and take only the Vitamin D provided by the study. Exclusion Criteria: * Presence of any Metastatic lesion. * History of parathyroid disease, hypercalcemia, or kidney stones. * History of Selective estrogen receptor modulator (SERM) or aromatase inhibitor therapy. * Receiving metformin. * History of renal failure requiring dialysis or kidney transplantation. * Women who are known to be pregnant or who are nursing. (As vitamin D does not have toxicity to the fetus, a negative pregnancy test is not a requirement to participate in the study.) * Patients planned for surgical therapy of their breast cancer or initiation of systemic chemotherapy, that would not allow for at least 7 days of vitamin D intervention * Any condition potentially interfering with subjects ability to comply with taking study medication. * Any medical condition that would potentially interfere with vitamin D absorption. * Current participation in another research study that would increase risk to subject, in the opinion of the investigators. * Patients currently taking more than 2000 IU of Vitamin D.
References
Publications (0)
Data not yet available
No reference posted for this study.