Efficacy of Vitamin D in Colorectal Cancer Chemoprevention

NCT01574027 | Completed Phase 2

• 1 other identifier: R01CA122299
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Vitamin D's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30 years, but has never been directly studied in humans. The biologically active version of vitamin D, 1,25(OH)2D3, cannot be readily used in humans because of its tendency to cause serum calcium levels to rise. In contrast, 25(OH)D3 (ie calcifediol) does not have this side effect. The investigators previous research suggests that the enzyme necessary to convert 25(OH)D3 (calcifediol) into active 1,25(OH)D3 is present in cells lining the large intestine (colon). Aberrant crypt foci (ACF) are very small (ie microscopic) collections of abnormally shaped cells that are a commonly used marker of CRC risk. Screening colonoscopy at UIC routinely uses methods that allow ACF counting to be done as a part of standard practice. ACF's are not fixed, like polyps or cancers, but can disappear as a person's risk for developing CRC decreases. The investigators propose giving patient's with 10 or more ACF's 25(OH)D3 (calcifediol) or placebo, and determining if there is a drug-dependant decrease in ACF number. The primary objective is to determine whether 25(OH)D3 (calcifediol) supplementation, compared to placebo, causes significant reduction of ACF number from baseline levels. The primary endpoint will be change in ACF number.

Conditions

Colorectal Cancer

Keywords

Assess the efficacy of vitamin D for preventing colorectal cancer and identifying the populations likely (or unlikely) to benefit from vitamin D-based therapy.; Evaluate the ability of Vitamin D3 (cholecalciferol) to reduce ACF's in humans.

Outcome Measures

Primary Outcomes (1)

• Reduction in ACF biomarkers

  The investigators propose giving patient's with 10 or more ACF's 25(OH)D3 (calcifediol) or placebo, and determining if there is a drug-dependant decrease in ACF number. The primary objective is to determine whether 25(OH)D3 (calcifediol) supplementation, compared to placebo, causes significant reduction of ACF number from baseline levels. The primary endpoint will be change in ACF number.

  6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Some participants were given a placebo pill to take daily for the length of the study. The placebo patients were used as a control group to compare against those taking the Vitamin D supplement.

Drug: Placebo

Vitamin D3 (cholecalciferol)

EXPERIMENTAL

Other participants were administered Vitamin D3 (cholecalciferol) for the six month study duration to determine if it would decrease the number of aberrant crypt foci in the colon as compared to the baseline number.

Drug: Vitamin D3 (cholecalciferol)

Interventions

Vitamin D3 (cholecalciferol) DRUG

One capsule per day for six months

Vitamin D3 (cholecalciferol)

Placebo DRUG

One capsule per day for six months

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All non-pregnant patients 50 years of age or older with 10 or more ACFs.

You may not qualify if:

• The following will be specifically looked for, and result in patients not being eligible for study enrollment:
• Use of non-steroidal anti-inflammatory drugs or glucocorticosteroids within 60 days of study entry.
• History of chronic IBD or prior pelvic radiation (inflammation distorts crypt pattern).
• Intake of any vitamin D or calcium supplements within 60 days of study entry.
• Patients with increased bleeding risk from biopsy protocol (i.e. renal failure, decompensated cirrhosis, blood dyscrasia

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Richard V Benya, M.D.

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 30, 2012
• First Posted: April 10, 2012
• Study Start: April 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 10, 2012

Record last verified: 2012-04

Locations

US (1)