Status:
COMPLETED
Effect of Vitamin D and Calcium on Genes in the Colon
Lead Sponsor:
Rockefeller University
Conditions:
Colorectal Polyps
Colorectal Adenoma
Eligibility:
All Genders
48-72 years
Phase:
PHASE1
Brief 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 researcher...
Detailed Description
Study subjects participate for about 3 months. During this time, there is one outpatient visit, a 4 week inpatient period, a 4 week outpatient period known as a wash out period and finally another 4 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00298545
Start Date
November 1 2005
End Date
May 1 2009
Last Update
November 18 2011
Active Locations (1)
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1
Rockefeller University Hospital
New York, New York, United States, 10021