Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients

NCT04677816 · View on ClinicalTrials.gov ↗

Study Summary

A two arm pilot study investigating the rate of pathologic complete response in patients with vitamin D deficiency and triple negative breast cancer undergoing standard neoadjuvant chemotherapy + vitamin D supplementation, including an observational arm to describe response in patients who are not deficient. Investigators hypothesize that vitamin D supplementation during neoadjuvant chemotherapy in operable triple negative breast cancer patients with vitamin D deficiency, will increase the rate of pathologic complete response chain reaction to that of vitamin D sufficient patients based on historical controls.

Interventions

  • DRUG Standard of Care Neoadjuvant Chemotherapy (NAC)
  • DIETARY_SUPPLEMENT Vitamin D3
  • OTHER Drug Diary

Study Locations (1)

North Carolina

  • Wake Forest Baptist Health Sciences — Winston-Salem

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2021-10-22
Est. Completion 2026-08
Phase Phase 2

Sponsor

Wake Forest University Health Sciences

1,061 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04677816

The ClinicalTrials.gov registry entry for NCT04677816 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,061 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which Standard of Care Neoadjuvant Chemotherapy (NAC) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04677816 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04677816 about?

NCT04677816 is a clinical study titled "Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients". A two arm pilot study investigating the rate of pathologic complete response in patients with vitamin D deficiency and triple negative breast cancer undergoing standard neoadjuvant chemotherapy + vitamin D supplementation, including an observational arm to describe response in patients who are not d...

What is the current status of trial NCT04677816?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2021-10-22. Estimated completion is 2026-08.

What conditions does trial NCT04677816 study?

This clinical trial studies the following conditions: Triple Negative Breast Cancer, Vitamin D Deficiency, Invasive Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04677816?

The interventions under investigation include: Standard of Care Neoadjuvant Chemotherapy (NAC) (DRUG), Vitamin D3 (DIETARY_SUPPLEMENT), Drug Diary (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04677816?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,061 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04677816 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial