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

Conditions

• Stage I-III Colon Cancer
• Stage IV Colon Cancer With Resectable Liver Metastases
• Stage, Colon Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vitamin D3 — DRUG
  Take five 10,000 IU capsules (total 50,000 IU) once daily for 7 days, followed by one 10,000 IU capsule once daily until surgery.
• Placebo — DRUG
  Take five placebo capsules once daily for 7 days, followed by one placebo capsule once daily until surgery.

Study Details

This study seeks to learn more about the vitamin D receptor and its relationship to colon cancer. The Vitamin D receptor is found in colon cancer cells. When Vitamin D binds to the receptor in the cancer cells, it may stop cancer cells from growing abnormally and may cause cancer cell death. Vitamin D has been used in other research studies and information from those other research studies suggests that Vitamin D may help in the treatment of colon cancer. Participants will receive either high-dose vitamin D or standard-dose vitamin D. The study drug will be given 14-28 days prior to your surgery. The number of days will depend on when the surgery is scheduled.

Key Dates

Start date

Jul 14, 2014

Status verified

May 2026

Primary completion

Apr 15, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Vitamin D3 - Blinded Registration
  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.
• Placebo Comparator: Placebo - Blinded Registration
  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.

Primary Outcome Measure

VDR Binding Sites [ Time Frame: 14 to 28 days ]

Central Contacts

• Kimmie Ng, MD
  617-632-5960

Locations (1)

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