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NCT01816555 · ClinicalTrials.gov registry record · Phase 1
Vitamin D3 (Vit D3) Supplementation and T Cell Immunomodulation in Patients With Newly Diagnosed Operative Invasive Ductal Breast Carcinoma
A Phase 1 study, sponsored by Medical University of South Carolina.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT01816555 is a Phase 1 study that was terminated before completion, run by Medical University of South Carolina. The registered enrollment target is 1 participants.
The verdict
NCT01816555, a Phase 1 study, was terminated before completion, sponsored by Medical University of South Carolina.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
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.
Interventions
- DIETARY_SUPPLEMENT Vitamin D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01816555
The ClinicalTrials.gov registry entry for NCT01816555 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vitamin D is the first listed.
NCT01816555 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01816555 about?
NCT01816555 is a clinical study titled "Vitamin D3 (Vit D3) Supplementation and T Cell Immunomodulation in Patients With Newly Diagnosed Operative Invasive Ductal Breast Carcinoma". 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. E...
What is the current status of trial NCT01816555?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2013-01. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01816555?
The interventions under investigation include: Vitamin D (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01816555?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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