Vitamin D/Calcium Polyp Prevention Study

Summary

Extensive experimental and observational data suggest that intake of calcium and of vitamin D exert protective effects on colorectal neoplasia. Building on their previous work, the investigators will investigate the chemopreventive effect of vitamin D in the large bowel, to study whether calcium with vitamin D is more effective than calcium alone, and to confirm their positive finding regarding calcium. The goal of this study is the development of chemopreventive combinations that will reduce risk of colorectal neoplasia sufficiently to permit the lengthening of surveillance intervals in most patients and to clarify important issues regarding the mechanisms of colorectal carcinogenesis and chemoprevention.

Timeline

Start

2004-07

Primary completion

2013-10

Completion

2016-06

Outcome

Missed primary endpoint

paper Daily supplementation with vitamin D3 (1000 IU), calcium (1200 mg), or both after removal of colorectal adenomas did not significantly reduce the risk of recurrent colorectal adenomas PMID 26465985 ↗

Publications

• Gibbs DC, Barry EL, Fedirko V, Baron JA, Bostick RM. Impact of Common Vitamin D-Binding Protein Isoforms on Supplemental Vitamin D3 and/or Calcium Effects on Colorectal Adenoma Recurrence Risk: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2023 Apr 1;9(4):546-551. doi: 10.1001/jamaoncol.2022.6924.
• Passarelli MN, Mott LA, Barry EL, Rees JR, Baron JA. Oral Antibiotics and Risk of New Colorectal Adenomas During Surveillance Follow-up. Cancer Epidemiol Biomarkers Prev. 2021 Oct;30(10):1974-1976. doi: 10.1158/1055-9965.EPI-21-0323. Epub 2021 Jul 21.
• Passarelli MN, Karagas MR, Mott LA, Rees JR, Barry EL, Baron JA. Risk of keratinocyte carcinomas with vitamin D and calcium supplementation: a secondary analysis of a randomized clinical trial. Am J Clin Nutr. 2020 Dec 10;112(6):1532-1539. doi: 10.1093/ajcn/nqaa267.
• Crockett SD, Barry EL, Mott LA, Ahnen DJ, Robertson DJ, Anderson JC, Wallace K, Burke CA, Bresalier RS, Figueiredo JC, Snover DC, Baron JA. Calcium and vitamin D supplementation and increased risk of serrated polyps: results from a randomised clinical trial. Gut. 2019 Mar;68(3):475-486. doi: 10.1136/gutjnl-2017-315242. Epub 2018 Mar 1.
• Anderson JC, Morris CB, Robertson DJ, Barry ELR, Figueiredo JC, Cruz-Correa M, Bostick RM, Ahnen DJ, Baron JA. Can the Sum of Adenoma Diameters (Adenoma Bulk) on Index Examination Predict Risk of Metachronous Advanced Neoplasia? J Clin Gastroenterol. 2018 Aug;52(7):628-634. doi: 10.1097/MCG.0000000000000899.
• Barry EL, Peacock JL, Rees JR, Bostick RM, Robertson DJ, Bresalier RS, Baron JA. Vitamin D Receptor Genotype, Vitamin D3 Supplementation, and Risk of Colorectal Adenomas: A Randomized Clinical Trial. JAMA Oncol. 2017 May 1;3(5):628-635. doi: 10.1001/jamaoncol.2016.5917.
• Rees JR, Mott LA, Barry EL, Baron JA, Bostick RM, Figueiredo JC, Bresalier RS, Robertson DJ, Peacock JL. Lifestyle and Other Factors Explain One-Half of the Variability in the Serum 25-Hydroxyvitamin D Response to Cholecalciferol Supplementation in Healthy Adults. J Nutr. 2016 Nov;146(11):2312-2324. doi: 10.3945/jn.116.236323. Epub 2016 Sep 28.
• Rees JR, Mott LA, Barry EL, Baron JA, Figueiredo JC, Robertson DJ, Bresalier RS, Peacock JL. Randomized controlled trials: who fails run-in? Trials. 2016 Jul 29;17:374. doi: 10.1186/s13063-016-1451-9.
• Baron JA, Barry EL, Mott LA, Rees JR, Sandler RS, Snover DC, Bostick RM, Ivanova A, Cole BF, Ahnen DJ, Beck GJ, Bresalier RS, Burke CA, Church TR, Cruz-Correa M, Figueiredo JC, Goodman M, Kim AS, Robertson DJ, Rothstein R, Shaukat A, Seabrook ME, Summers RW. A Trial of Calcium and Vitamin D for the Prevention of Colorectal Adenomas. N Engl J Med. 2015 Oct 15;373(16):1519-30. doi: 10.1056/NEJMoa1500409.
• Barry EL, Mott LA, Melamed ML, Rees JR, Ivanova A, Sandler RS, Ahnen DJ, Bresalier RS, Summers RW, Bostick RM, Baron JA. Calcium supplementation increases blood creatinine concentration in a randomized controlled trial. PLoS One. 2014 Oct 15;9(10):e108094. doi: 10.1371/journal.pone.0108094. eCollection 2014.
• Barry EL, Rees JR, Peacock JL, Mott LA, Amos CI, Bostick RM, Figueiredo JC, Ahnen DJ, Bresalier RS, Burke CA, Baron JA. Genetic variants in CYP2R1, CYP24A1, and VDR modify the efficacy of vitamin D3 supplementation for increasing serum 25-hydroxyvitamin D levels in a randomized controlled trial. J Clin Endocrinol Metab. 2014 Oct;99(10):E2133-7. doi: 10.1210/jc.2014-1389. Epub 2014 Jul 29.
• Rees JR, Hendricks K, Barry EL, Peacock JL, Mott LA, Sandler RS, Bresalier RS, Goodman M, Bostick RM, Baron JA. Vitamin D3 supplementation and upper respiratory tract infections in a randomized, controlled trial. Clin Infect Dis. 2013 Nov;57(10):1384-92. doi: 10.1093/cid/cit549. Epub 2013 Sep 6.
• Bischoff-Ferrari HA, Rees JR, Grau MV, Barry E, Gui J, Baron JA. Effect of calcium supplementation on fracture risk: a double-blind randomized controlled trial. Am J Clin Nutr. 2008 Jun;87(6):1945-51. doi: 10.1093/ajcn/87.6.1945.

Drugs

Indications