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Vitamin D3 (Vit D3) Supplementation and T Cell Immunomodulation in Patients With Newly Diagnosed Operative Invasive Ductal Breast Carcinoma

NCT01816555 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2015-07-22

No results posted yet for this study

Summary

This study is for adult females who have been newly diagnosed with breast cancer that includes surgery as part of standard cancer treatment. This is a research study combining Vitamin D (an over the counter medication) with the standard of care (or the established and approved treatment), surgery. Evidence shows that women who are Vitamin D3 deficient have a higher risk of breast cancer and breast cancer recurrence. The purpose of this study is to find out the effects of Vitamin D3 during the treatment period for Stage I-II breast cancer. Screening tests will be done to determine if subjects are eligible to participate in this study. If subjects are eligible and they agree to participate, they will be assigned to one of two groups which will receive different amounts of vitamin D. Subjects will be asked to keep a medication diary. Subjects may remain on treatment for approximately 56 days.

Conditions

  • Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II

Interventions

DIETARY_SUPPLEMENT

Vitamin D

Subjects will be assigned to a dosage level between 600IU daily and 10,000IU daily depending on their age, weight and current vitamin D level

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01816555 on ClinicalTrials.gov