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Effect of Vitamin D and Calcium on Genes in the Colon

NCT00298545 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2011-11-18

No results posted yet for this study

Summary

The researchers are involved in a research program to understand how vitamin D and calcium in the diet or as supplements may lower the risk of colorectal polyps and cancer. To that end, the researchers are conducting a study of vitamin D supplementation in which volunteer subjects are provided a Western style diet for 2 separate 4 week periods at the Rockefeller University Hospital. During one of these 4 week inpatient periods, subjects receive calcium supplements and during the other 4 week inpatient period they receive a placebo tablet. The researchers determine changes within the colon as a result of supplementing the vitamin D in the presence of high and low calcium. A more detailed description of the study is provided below.

Conditions

  • Colorectal Polyps
  • Colorectal Adenoma
  • Adenocarcinoma

Interventions

DRUG

placebo and Calcitriol

Placebo tablets twice daily together with an oral tablet of 1, 25 dihydroxy vitamin D3 (Calcitriol)

DRUG

Calcium and Calcitriol

Calcium twice daily together with an oral tablet of 1, 25 dihydroxy vitamin D3 (Calcitriol)

Sponsors & Collaborators

  • Rockefeller University

    lead OTHER

Principal Investigators

  • Peter Holt, MD · Rockefeller University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
48 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00298545 on ClinicalTrials.gov