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High-Dose Vitamin D3 for Colon Cancer

Phase < 1
Recruiting
Led By Kimmie Ng, MD, MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Participants must have histologically confirmed adenocarcinoma of the colon that is localized, with no evidence of distant metastasis (stage I, II, or III), and for which surgical resection of the primary tumor is being planned
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 to 28 days
Awards & highlights

Study Summary

This trial is testing if high-dose vitamin D will help treat colon cancer by binding to the vitamin D receptor in cancer cells.

Who is the study for?
This trial is for adults with stage I-III colon cancer or resectable liver metastases from colon cancer, who haven't had recent chemotherapy or radiation. They must be able to swallow pills, not have a history of allergic reactions to vitamin D, and should not be on certain medications like thiazide diuretics. Pregnant women and those unable to use contraception are excluded.Check my eligibility
What is being tested?
The study tests high-dose versus standard-dose vitamin D given before surgery for colon cancer. It aims to understand how vitamin D affects the growth and death of cancer cells by interacting with the vitamin D receptor in these cells.See study design
What are the potential side effects?
Potential side effects may include hypercalcemia (high calcium levels), digestive issues that affect pill absorption, allergic reactions if sensitive to vitamin D compounds, and possibly an increased risk of kidney stones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My colon cancer is confirmed, hasn't spread far, and surgery is planned.
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I have colon cancer with liver metastases that can be surgically removed.
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I have not had radiation or systemic treatment for my stage I, II, or III colon cancer.
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I am fully active and can carry on all pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 to 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 to 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
VDR Binding Sites
Secondary outcome measures
Number of Participants with Serious and Non-Serious Adverse Events
RNA transcriptome

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vitamin D3 - Blinded RegistrationExperimental Treatment1 Intervention
One capsule of vitamin D3 10,000 IU orally once daily for 14 days until the date of surgery. To allow for some flexibility in the scheduling of surgery, patients can be treated with preoperative vitamin D3 for up to 28 days. On the morning of surgery, prior to operating, a second blood sample will be collected for follow-up 25(OH)D, calcium, and albumin determination. Colon and liver resection will occur per institutional standards of care, and malignant and adjacent benign tissue will be collected for the laboratory endpoints described in this protocol.
Group II: Placebo - Blinded RegistrationPlacebo Group1 Intervention
One placebo capsule orally once daily for 14 days until the date of surgery. To allow for some flexibility in the scheduling of surgery, patients can be treated with preoperative placebo for up to 28 days. On the morning of surgery, prior to operating, a second blood sample will be collected for follow-up 25(OH)D, calcium, and albumin determination. Colon and liver resection will occur per institutional standards of care, and malignant and adjacent benign tissue will be collected for the laboratory endpoints described in this protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D3
2011
Completed Phase 4
~3590

Find a Location

Who is running the clinical trial?

Pharmavite LLCIndustry Sponsor
9 Previous Clinical Trials
26,654 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,284 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,080 Previous Clinical Trials
340,850 Total Patients Enrolled

Media Library

Vitamin D3 Clinical Trial Eligibility Overview. Trial Name: NCT02172651 — Phase < 1
Colon Cancer Research Study Groups: Placebo - Blinded Registration, Vitamin D3 - Blinded Registration
Colon Cancer Clinical Trial 2023: Vitamin D3 Highlights & Side Effects. Trial Name: NCT02172651 — Phase < 1
Vitamin D3 2023 Treatment Timeline for Medical Study. Trial Name: NCT02172651 — Phase < 1
~6 spots leftby Mar 2025
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