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Study Summary
No. 2004-0078:.......Cancer Prevention; Colorectal......Robert S. Bresalier......Gastroenterology/Hepatology and Nutrition
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Study Summary Title
Study Summary
Number:
2004-0078
Study Title:Vitamin D / Calcium Polyp Prevention Study
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Physician New Patient Referral
Name:Robert S. BresalierPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Gastroenterology/Hepatology and NutritionReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-794-5073
Contact us about clinical trials
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General Information
Disease Group:Cancer Prevention
Colorectal
Supported By:N/A
Phase of Study:N/AReturn
Visit:
3 -4 times
Treatment
Agents:
Calcium Carbonate
Vitamin D
Home Care:None required
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
No hospitalization is required
Description/
Intervention:
The goal of the biomarker portion of this study is to find out whether getting
more calcium or vitamin D in the diet can lower the chances for future colon
polyps or colon cancer by returning certain changes (biomarkers of risk) in the
lining of the colon to a more normal level or pattern. Researchers want to
develop new tests to help in preventing polyps and cancer of the colon, or
large bowel.
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Study Objectives / Outcomes
There is compelling evidence that most colorectal cancers arise from adenomatous tissue, suggesting that prevention of adenomas would prevent colorectal cancer. It has been recently documented that calcium supplementation inhibits the development of adenomas in the large bowel, and there is good evidence that vitamin D may also protect against colorectal neoplasia. We now wish to extend this work by studying the chemopreventive effects of vitamin D on colorectal neoplasia, and by investigating whether calcium in combination with vitamin D is more effective than calcium alone in suppressing colorectal neoplasia.

Our main hypotheses are:
1. Supplementation with vitamin D3 (1000 IU/day) alone reduces the risk of new adenomas in patients with a recent history of these tumors.
2. Supplementation with calcium carbonate (1200 mg calcium/day) alone reduces the risk of new adenomas
3. Supplementation with both vitamin D3 (1000 IU/day) and calcium carbonate (1200 mg calcium/day) reduces the risk of new adenomas more than supplementation with calcium carbonate alone.

Our secondary hypotheses are:
4. Supplementation with vitamin D3, or with vitamin D3 plus calcium carbonate reduces the risk of new advanced colorectal lesions (colorectal) cancer and adenomas with an estimated diameter of on e centimeter or greater, those with tubulovillous or villous histology, or those with advanced dysplasia).
5. Supplementation with vitamin D3 will have a greater effect among individuals whose initial serum 25-OH vitamin D level is less than the overall median, compared with subjects whose levels are greater than the median.
6. The effect of supplementation with vitamin D3 will be modified by polymorphisms at the 3' end of the vitamin D receptor gene.

In addition to the primary and secondary hypotheses, we are investigating benefits and risks associated with calcium and vitamin D supplementation.
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Study Status Information
Study Activation / Registration Date:06/01/2004
IRB Review and Approval Date:04/07/2004
Study Type:Cancer Control
Recruitment Status:Open
Projected Accrual:3000
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) One or more histologically verified neoplastic polyps that is at least 2 mm in size removed from the large bowel within 120 days of study entry, with the entire large bowel examined by colonoscopy and documented to be free of further polyps

2) Anticipated colonoscopic follow-up three years or five years after the qualifying colonoscopy

3) Age between 45 and 75 years

4) Agreement to avoid pregnancy (i.e. use of standard contraception)

5) Willingness to forego calcium supplementation or, for women only, option of taking calcium supplementation of 1200 mg/daily (contained in the study pills)

6) Willingness to forego vitamin D supplementation

7) Agreement to daily dietary intake of the equivalent of not more than 1200 mg calcium

8) Agreement to daily dietary intake of the equivalent of not more than 400 IU vitamin D

9) Serum calcium within normal range

10) Serum creatinine within lower limit of normal to 20% above upper limit of normal

11) Serum 25-(OH)-vitamin D within lower limit of normal to 70 ng/ml

12) Ability and willingness to follow the study protocol, as indicated by provision of informed consent to participate

13) Good general health, with no severely debilitating diseases or active malignancy that might compromise the patient's ability to complete the study

Exclusion Criteria:1) Current participation in another colorectal (bowel) study

2) Current participation in any other clinical trial (intervention study)

3) Previous participation in another colorectal chemoprevention study

4) Pregnancy or lactation

5) Diagnosed narcotic or alcohol dependence

6) Dementia (e.g. Alzheimer's)

7) Significant psychiatric disability (e.g. Schizophrenia, refractory bipolar disorder, current severe depression)

8) A history of kidney stones

9) A history of granulomatous diseases: sarcoidosis (within 10 years), active chronic fungal or mycobacterial infections (tuberculosis, histoplasmosis, coccidioidomycosis, blastomycosis), Berylliosis, Wegener's granulomatosis

10) A history of hyperparathyroidism

11) Severe renal disease: chronic renal failure

12) A history of unexplained hypercalcemia

13) Diagnosed osteoporosis or physician recommendation for treatment of low bone mass

14) Two or more low trauma fractures

15) Medical condition requiring treatment with vitamin D (e.g. osteomalacia)

16) History of invasive carcinoma of the large bowel (even if confined to a polyp)

17) Familial colorectal cancer syndromes: Adenomatous Polyposis, HNPCC, Hamartomatous Polyposis syndromes, Noninherited Polyposis syndromes

18) History of inflammatory bowel disease: Crohn's Disease, Ulcerative Colitis

19) Chronic intestinal malabsorption syndromes: celiac sprue, bacterial overgrowth, chronic pancreatitis, pancreatic insufficiency

20) Previous gastrectomy, small bowel or large bowel resection

21) Malignancy, other than non-melanoma skin cancer

22) Severe lung disease – class 3 or 4 (COPD or emphysema requiring oxygen)

23) Severe heart disease: Cardiovascular disease functional class 3 or 4

24) Severe liver disease: Cirrhosis

25) HIV positive

26) Active hepatitis B or C

27) Use of chronic oral steroid therapy

28) Use of Lithium

29) Use of Phenytoins

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Links
Registration Number: NCT00153816
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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