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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: Clinical Trial Phase 1 study, sponsored by Medical University of South Carolina.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
T cell analysis for the following markers will be evaluated- 1. memory markers 2. activation status and presence of regulatory T cells 3. lymphoid organ-homing receptors 4. Functional status of gated T cells will be analyzed 5. cell surface thiol molecules and intracellular glutathione using flow cytometry to evaluate if anti-oxidant stus of the T cells is modulated in presence of the Vitamin D. These markers will help in determining the immunomodulatory potential of Vitamin D on T cell with r
Interventions
- DIETARY_SUPPLEMENT Vitamin D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
Why NCT01816555 stopped before completion
NCT01816555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Vitamin D is the first listed.
NCT01816555 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01816555's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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