- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00298545
Effect of Vitamin D and Calcium on Genes in the Colon
High vs. Low Calcium Intake in the Presence of High Vitamin D: Effect on Gene Expression in the Colon
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Rockefeller University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Volunteers with a history of pre-cancerous colorectal polyps and/or have a family history of pre-cancerous polyps or colon cancer
- Not taking any medications known to affect either calcium metabolism or colon function
- Between the ages of 48 and 72 years old
- Have had pre-cancerous colorectal polyps or have first or second degree relatives with colorectal cancer and are therefore at increased risk for the disease
Exclusion Criteria:
- Personal history of cancer other than non-melanoma skin cancer
- Diseases of the bowel such as intestinal malabsorption or inflammatory bowel disease
- Prior gastrointestinal surgery including gastrectomy, small or large bowel resections. (If one has had an appendectomy or surgery of the esophagus, he/she is still eligible.)
- Any excessive bleeding or clotting disorders
- Taking blood thinners
- Abnormalities of or conditions predisposing one to abnormalities of calcium metabolism. (This includes untreated hyperparathyroidism [increase in parathyroid function] and history of milk-alkali syndrome, a type of calcium metabolism disease.)
- Untreated hyperthyroidism (increase in thyroid function)
Regularly take greater than 660 mg of aspirin per day. This is greater than two tablets of 325 mg regular strength aspirin or greater than one tablet of 500 mg of extra strength aspirin per day. (If one has been taking aspirin for heart or blood vessel protection regularly for at least one month before his/her first screening visit, he/she will remain on the same amount of medicine throughout the study. The following amounts are acceptable:
- Aspirin 1 to 2 regular tablets (325 mg) per day, or
- Baby aspirin 1 tablet (81 mg) per day
- Regularly take daily dosages of nonsteroidal anti-inflammatory agents (NSAIDs) within the last 3 months. (One example of an NSAID is ibuprofen.)
- Taking greater than 1200 mg of dietary calcium daily
- Taking medications called sterol-binding resins, such as cholestyramine (Questran®), which is for the treatment of high blood cholesterol
- Taking other investigational drugs or multiple other medications that might, in the opinion of the investigator, affect the study measurements.
- Other serious illness(es) that are anticipated to limit life expectancy to less than 6 months
- Elevated blood pressure greater than 160/100 mmHg
- HIV positive
- Pregnant or nursing
- A history of kidney stones
- Liver disease and/or kidney disease
- Diabetes mellitus
- High "bad" cholesterol level, low density lipoprotein (LDL) greater than 175 mg/dl or triglyceride levels greater than 600 mg/dl
- Known history of coronary artery disease
- EKG (electrocardiogram is a record of the electrical activity of the heart) changes consistent with a past heart attack (myocardial infraction)
Currently taking:
- Antidiabetic medication
- Hormone replacement therapies, oral, injected or implanted contraceptives. (Thyroid hormone replacement is allowed as long as one's thyroid test is normal.)
- Vitamin, mineral, fish oil, and herbal supplementation and weight control medication must be stopped at least 1 month prior to enrolling in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo and Calcitriol
placebo tablets together with an oral tablet of 1, 25 dihydroxy vitamin D3 (Calcitriol)
|
Placebo tablets twice daily together with an oral tablet of 1, 25 dihydroxy vitamin D3 (Calcitriol)
|
Active Comparator: 2
calcium together with an oral tablet of 1, 25 dihydroxy vitamin D3 (Calcitriol)
|
Calcium twice daily together with an oral tablet of 1, 25 dihydroxy vitamin D3 (Calcitriol)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Gene expression related to proliferation, apoptosis, and differentiation of human rectal mucosal cells
Time Frame: end of study
|
end of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Expression of additional genes involved in the cell properties noted above
Time Frame: end of study
|
end of study
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter Holt, MD, Rockefeller University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Adenoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Micronutrients
- Membrane Transport Modulators
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vasoconstrictor Agents
- Calcium Channel Agonists
- Calcium
- Calcitriol
Other Study ID Numbers
- RUH IRB # PHO-0554
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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