Vitamin D Supplementation in Women With DCIS and/or LCIS

Stopped early · Early Phase 1

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02936999

Run by

Inova Health Care Services

People needed

8

Starts

2016-08-01

Expected to finish

2019-01-01

Last updated by the study team

2020-12-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Inova Schar Cancer Institute — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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