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Appendix 3. Additional Information on Randomized Controlled Trials of Vitamin Supplementation to Prevent Cancer

(Supplement to Table 1)

Study, Year Treatment (n) Control (n) Exclusion Criteria # Enrolled/
# Screened
Other Nutrients Supplemented Compliance Method,
Rate
Jadad Score
Beta-carotene
Hennekens, 19968
Physicians' Health Study
11,036 11,035 History of cancer, MI, stroke, cerebral ischemia 22,071 enrolled Aspirin; 4% on placebo took BC or vitamin A. Pill count; 78% at year 12 4
Alpha-Tocopherol Beta-Carotene (ATBC) Study Group, 19949 13,602 13,669 Prior MI, severe angina, proven malignancy, chronic renal insufficiency, cirrhosis, alcoholism, anticoagulant therapy, any current use of vitamin A, vitamin E, BC, other serious medical illness 42,957 screened; 29,246 enrolled; 29,133 randomized; 22,269 included Co-intervention with vitamin E Pill count 99% 5
Greenberg, 199411
Polyp Prevention Study
BC, 184; vit C+E, 205; all, 175 187 FAP, history of cancer, malabsorption, renal calculi, thrombophlebitis 2092 screened; 981 signed; 864 randomized Go to Table 1. <82% at yr 4 5
MacLennan, 199512
Australian Polyp Prevention Study
BC, 53; BC+low fat, 51; BC+C+bran, 47; low fat+bran+BC, 50 48 Chronic IBD, GI tract resection, FAP, cancer history, renal, liver, GB disease 2780 cx; 1304 potential; 559 eligible; 424 randomized Go to Table 1. No data 3
I-M Lee, 199910
Women's Health Study
BC, 19,939 19,937 History of cancer, coronary heart disease, or cerebrovascular disease 65,169 eligible; 39,876 randomized Vitamin E After 2 years, 87% of active group reported taking at least 2/3 of capsules. 4
DeKlerk, 199815
Mesothelioma Prevention Study
BC, 512; retinyl palmitate, 512 none   1203 joined; 1024 randomized   Pill counts @ 1 year, 100%.  Process discontinued 3
Vitamin E
Alpha-Tocopherol Beta-Carotene (ATBC) Study Group, 19949 Go to ATBC citation above.
Multivitamin and antioxidant combinations
Greenberg, 199411
Polyp Prevention Study
Go to Greenberg citation above.
Omenn, 199614
CARET
2044 asbestos workers; 7376 smokers 2016 asbestos workers; 6878 smokers Limited vitamin A use and no BC supplement use 4060 workers exposed to asbestos; 14,254 heavy smokers (44% female) randomized Retinol and BC cointervention;  2% took additional BC; 1% took vitamin A. Weighed capsules or self report in 15% 4
McKeown-Eyssen, 198825 96 89 Unwilling to stop supplementation; no adenomatous polyps (n=15) 200 signed; 185 randomized Intervention group more likely to have taken supplement prior to randomization 95% based on urinary ascorbate in intervention group; slightly fewer completed in placebo group. 5
Ponz de Leon, 199726
Italian Polyp Prevention Study
70 Lactulose 61; no treatment, 78   255 randomized 3 follow-up colonoscopies:  6-8 months, 12-18 months, 24-36 months   3

Note:  n indicates number; ATBC, Alpha-Tocopherol Beta-Carotene; MI, myocardial infarction; BC, beta-carotene; FAP, familial adenomatous polyposis;  GB, gall bladder; CARET, Beta-Carotene and Retinol Efficacy Trial.

Return to Table 1

 

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