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High-Dose Vitamin D3 for Colon Cancer

Q: How is Vitamin D3 typically utilized to promote health?

Vitamin D3 can be administered to manage calcium deficiency and related issues including spine fracture, post menopausal women, and fractures.

Q: Are there any opportunities still available to partake in this research?

According to clinicaltrials.gov, this medical research is actively seeking participants; it was initially announced on July 14th 2014 and recently updated on May 18th 2022.

Q: Can you share details of other scientific investigations that have utilized Vitamin D3?

At present, 33 trials are currently exploring the potential of Vitamin D3 as a therapeutic intervention. Of those, 14 have reached Phase 3. The bulk of these studies are happening in Rochester, <a href="https://www.withpower.com/clinical-trials/minnesota">Minnesota</a>; however there exist 155 sites globally with active investigations into this medication's efficacy.

Q: How many participants are currently enrolled in the research initiative?

Yes, the information on clinicaltrials.gov confirms that this trial is actively seeking out participants. It was first posted on July 14th 2014 and last updated on May 18th 2022; they are looking to enroll 80 people across one facility.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 to 28 days

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

0 / 5Eligibility criteria met

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

13,665 Previous Clinical Trials

40,925,774 Total Patients Enrolled

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,901 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is Vitamin D3 typically utilized to promote health?

"Vitamin D3 can be administered to manage calcium deficiency and related issues including spine fracture, post menopausal women, and fractures."

Answered by AI

Are there any opportunities still available to partake in this research?

"According to clinicaltrials.gov, this medical research is actively seeking participants; it was initially announced on July 14th 2014 and recently updated on May 18th 2022."

Answered by AI

Can you share details of other scientific investigations that have utilized Vitamin D3?

"At present, 33 trials are currently exploring the potential of Vitamin D3 as a therapeutic intervention. Of those, 14 have reached Phase 3. The bulk of these studies are happening in Rochester, Minnesota; however there exist 155 sites globally with active investigations into this medication's efficacy."

Answered by AI

How many participants are currently enrolled in the research initiative?

"Yes, the information on clinicaltrials.gov confirms that this trial is actively seeking out participants. It was first posted on July 14th 2014 and last updated on May 18th 2022; they are looking to enroll 80 people across one facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vitamin D in Patients With Stage I-III Colon Cancer or Resectable Colon Cancer Liver Metastases

Kimmie Ng, MD 2014. "Vitamin D in Patients With Stage I-III Colon Cancer or Resectable Colon Cancer Liver Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02172651.

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