Overview

Vitamin D Supplementation in Women With DCIS and/or LCIS

Status:
Terminated

Trial end date:
2019-01-01

Target enrollment:
0

Participant gender:
Female

Summary

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.

Phase:

Early Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Inova Health Care Services

Treatments:

Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins

Criteria

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