Vitamin D in Patients With Stage I-III Colon Cancer or Resectable Colon Cancer Liver Metastases
NCT02172651 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-05-13
Summary
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.
Conditions
- Stage, Colon Cancer
- Stage I-III Colon Cancer
- Stage IV Colon Cancer With Resectable Liver Metastases
Interventions
- DRUG
-
Vitamin D3
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.
- DRUG
-
Take five placebo capsules once daily for 7 days, followed by one placebo capsule once daily until surgery.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Pharmavite LLC
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Kimmie Ng, MD, MPH · Dana-Farber Cancer Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- TRIPLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-07-14
- Primary Completion
- 2027-04-15
- Completion
- 2027-06-30
Countries
- United States
Study Locations
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