We propose to conduct a randomized double-blind placebo controlled, two by two factorial design clinical trial of the efficacy of nutritional supplements in preventing adenomatous polyps of the large bowel in persons at high risk for this condition. This is a collaborative investigation to be conducted at six study centers with a central data coordinating center. Eligible subjects will have had an adenomatous polyp removed within three months of recruitment. Study participants will be assigned at random to one of four treatment groups: (a) 25mg of beta carotene per day, (b) one gram of Vitamin C (ascorbic acid) and 400 mg of Vitamin E (alpha tocopherol) per day, (c) 25mg of beta carotene, one gram of Vitamin C, and 400 mg of Vitamin E per day, and (d) a placebo regimen. They will be monitored for toxicity and compliance to the drug regimen at six monthly intervals throughout the study. At twelve months and 36 months after study entry subjects will receive a complete colonoscopy with removal and microscopic examination of all polypoid lesions. Blood will be drawn and analyzed for beta carotene, retinol, alpha tocopherol, zinc, selenium, and retinol binding protein. The study is designed to detect a 35% reduction in polyp incidence attributable to either beta carotene or Vitamin C and E supplementation. It will also permit an investigation of possible synergistic effects between the carotenoid and antioxidant therapies.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01CA037287-05
Application #
3548376
Study Section
(SSS)
Project Start
1984-09-01
Project End
1989-08-31
Budget Start
1988-09-01
Budget End
1989-08-31
Support Year
5
Fiscal Year
1988
Total Cost
Indirect Cost
Name
Dartmouth College
Department
Type
Schools of Medicine
DUNS #
041027822
City
Hanover
State
NH
Country
United States
Zip Code
03755
Robertson, Douglas J; Lieberman, David A; Winawer, Sidney J et al. (2014) Colorectal cancers soon after colonoscopy: a pooled multicohort analysis. Gut 63:949-56
Martínez, María Elena; Thompson, Patricia; Messer, Karen et al. (2012) One-year risk for advanced colorectal neoplasia: U.S. versus U.K. risk-stratification guidelines. Ann Intern Med 157:856-64
Shaukat, Aasma; Grau, Maria V; Church, Timothy R et al. (2011) Serum salicylate levels and risk of recurrent colorectal adenomas. Cancer Epidemiol Biomarkers Prev 20:679-82
Jacobs, Elizabeth T; Ahnen, Dennis J; Ashbeck, Erin L et al. (2009) Association between body mass index and colorectal neoplasia at follow-up colonoscopy: a pooling study. Am J Epidemiol 169:657-66
Martínez, María Elena; Baron, John A; Lieberman, David A et al. (2009) A pooled analysis of advanced colorectal neoplasia diagnoses after colonoscopic polypectomy. Gastroenterology 136:832-41
Wallace, Kristin; Grau, Maria V; Ahnen, Dennis et al. (2009) The association of lifestyle and dietary factors with the risk for serrated polyps of the colorectum. Cancer Epidemiol Biomarkers Prev 18:2310-7
Bischoff-Ferrari, Heike A; Rees, Judy R; Grau, Maria V et al. (2008) Effect of calcium supplementation on fracture risk: a double-blind randomized controlled trial. Am J Clin Nutr 87:1945-51
Wallace, Kristin; Baron, John A; Karagas, Margaret R et al. (2005) The association of physical activity and body mass index with the risk of large bowel polyps. Cancer Epidemiol Biomarkers Prev 14:2082-6
Baron, John A; Beach, Michael; Wallace, Kristin et al. (2005) Risk of prostate cancer in a randomized clinical trial of calcium supplementation. Cancer Epidemiol Biomarkers Prev 14:586-9
Wallace, Kristin; Baron, John A; Cole, Bernard F et al. (2004) Effect of calcium supplementation on the risk of large bowel polyps. J Natl Cancer Inst 96:921-5

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