Clinical trial · Interventional
Vitamin D Supplementation in Women With DCIS and/or LCIS
An Exploratory Pilot Study of Vitamin D Supplementation in Women With DCIS and/or LCIS
NCT02936999CI-TRIAL-00048845terminatedEarly Phase 1Results 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): Terminated for lack of patient samples and funding
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety and usefulness of oral Vitamin D supplementation in subjects with in situ carcinoma. More specifically, this study is being done to (1) understand the effect of Vitamin D supplementation on behavior of breast cancer cells and (2) the development of invasive breast cancer disease.
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 |
|---|---|---|---|
| Cholecalciferol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vitamin D3
- description
- Patients will be dispensed cholecalciferol, 32 capsules/bottle of 1cap/4000 IU PO QD on Day 1 visit to take home. Bottle must be labeled with instructions on how to take the drug and the assigned patient ID number. Patients will be instructed to take 1 capsule per day, with water, for 29 days using the dispensed study bottle. They will be instructed to stop taking their daily vitamin D3 dose after 30 days of treatment. A study drug diary will be provided at Day 1 visit and patients will be instructed to complete the study drug diary daily from Day 2 to Day 30. Patient's report of vitamin-D3 intake from the diary must be reconciled against the number of capsules returned at Day 30 visit.
- interventionNames
- Drug: Cholecalciferol
Primary outcomes (1)
- measure
- Ki 67 Measured
- timeFrame
- 28 days +/- 3 days from Day 1 of treatment
- description
- The proliferation index measured by Ki67 will be described for both baseline (pre) and surgical (post) vitamin D supplementation. A paired t-test or the non-parametric Wilcoxon signed-rank test will be used when appropriate to compare patients' outcome between baseline and after-treatment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must have a tissue diagnosis of lobular carcinoma in situ or ductal carcinoma in situ and being scheduled to undergo excision of their cancer * Subjects must be female at least 18 years of age * Subjects must have a signed consent * Normal liver function based on (total bilirubin and AST \<1.5 x Upper Limit of Normal) * Serum creatinine \< 2.0 mg/dL * Serum 25 (OH) D levels \< 50 ng/ml * Calcium within the normal range (8.5-10.2 mg/dL) * ECOG performance status 0-2 * Are able to swallow and retain oral medication * Subjects should be willing to abstain from use of hormonal therapies (e.g. hormone replacement therapy, oral contraceptive pills, hormone-containing IUDs, and E-string) Exclusion Criteria: * Patient desires not to participate in the study * Inability to give consent * Current use of hormone-containing forms of birth control such as implants (i.e. Norplants, or injectables (i.e. depo-provera) * Currently lactating * Patients with history of renal or hepatic insufficiency * Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication * History of granulomatous disease such as tuberculosis or sarcoidosis * History of Vitamin D supplementation \> 2000 IU/day within the last 2 months * History of hypoparathyroidism
References
Publications (32)
- BACKGROUNDBernardes JR Jr, Nonogaki S, Seixas MT, Rodrigues de Lima G, Baracat EC, Gebrim LH. Effect of a half dose of tamoxifen on proliferative activity in normal breast tissue. Int J Gynaecol Obstet. 1999 Oct;67(1):33-8. doi: 10.1016/s0020-7292(99)00092-2. PMID 10576237
- BACKGROUNDChen YY, DeVries S, Anderson J, Lessing J, Swain R, Chin K, Shim V, Esserman LJ, Waldman FM, Hwang ES. Pathologic and biologic response to preoperative endocrine therapy in patients with ER-positive ductal carcinoma in situ. BMC Cancer. 2009 Aug 18;9:285. doi: 10.1186/1471-2407-9-285. PMID 19689789
- BACKGROUNDDeeb KK, Trump DL, Johnson CS. Vitamin D signalling pathways in cancer: potential for anticancer therapeutics. Nat Rev Cancer. 2007 Sep;7(9):684-700. doi: 10.1038/nrc2196. PMID 17721433
- BACKGROUNDEspina V, Edmiston KH, Liotta LA. Non-enzymatic, serum-free tissue culture of pre-invasive breast lesions for spontaneous generation of mammospheres. J Vis Exp. 2014 Nov 8;(93):e51926. doi: 10.3791/51926. PMID 25406584
- BACKGROUNDEspina V, Liotta LA. What is the malignant nature of human ductal carcinoma in situ? Nat Rev Cancer. 2011 Jan;11(1):68-75. doi: 10.1038/nrc2950. Epub 2010 Dec 2. PMID 21150936
- BACKGROUNDEspina V, Mariani BD, Gallagher RI, Tran K, Banks S, Wiedemann J, Huryk H, Mueller C, Adamo L, Deng J, Petricoin EF, Pastore L, Zaman S, Menezes G, Mize J, Johal J, Edmiston K, Liotta LA. Malignant precursor cells pre-exist in human breast DCIS and require autophagy for survival. PLoS One. 2010 Apr 20;5(4):e10240. doi: 10.1371/journal.pone.0010240. PMID 20421921
- BACKGROUNDEsserman L. Neoadjuvant chemotherapy for primary breast cancer: lessons learned and opportunities to optimize therapy. Ann Surg Oncol. 2004 Jan;11(1 Suppl):3S-8S. doi: 10.1007/BF02524789. No abstract available.