一项关于钙和维生素D预防结直肠腺瘤的试验。
A Trial of Calcium and Vitamin D for the Prevention of Colorectal Adenomas.
作者信息
Baron John A, Barry Elizabeth L, Mott Leila A, Rees Judy R, Sandler Robert S, Snover Dale C, Bostick Roberd M, Ivanova Anastasia, Cole Bernard F, Ahnen Dennis J, Beck Gerald J, Bresalier Robert S, Burke Carol A, Church Timothy R, Cruz-Correa Marcia, Figueiredo Jane C, Goodman Michael, Kim Adam S, Robertson Douglas J, Rothstein Richard, Shaukat Aasma, Seabrook March E, Summers Robert W
机构信息
From the Departments of Medicine (J.A.B., D.J.R., R.R.) and Epidemiology (J.A.B., E.L.B., L.A.M., J.R.R.), Geisel School of Medicine at Dartmouth, Hanover, and Department of Medicine, Dartmouth-Hitchcock Medical Center, Lebanon (D.J.R., R.R.) - both in New Hampshire; the Departments of Medicine (J.A.B., R.S.S.) and Biostatistics (A.I.), University of North Carolina at Chapel Hill, Chapel Hill; the Department of Pathology, Fairview Southdale Hospital, Edina (D.C.S.), and the Division of Environmental Health Sciences, University of Minnesota School of Public Health (T.R.C.), Minnesota Gastroenterology (A.S.K.), Department of Medicine, University of Minnesota (A.S.), and Minneapolis Veterans Affairs (VA) Medical Center (A.S.), Minneapolis - all in Minnesota; the Department of Epidemiology, Rollins School of Public Health, Emory University and Winship Cancer Institute, Emory University, Atlanta (R.M.B., M.G.); the Department of Mathematics and Statistics, University of Vermont, Burlington (B.F.C.), and VA Outcomes Group, White River Junction (D.J.R.) - both in Vermont; the Department of Medicine, University of Colorado School of Medicine, Denver (D.J.A.); the Departments of Quantitative Health Sciences (G.J.B.) and Gastroenterology and Hepatology (C.A.B.), Cleveland Clinic, Cleveland; the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (R.S.B.); Puerto Rico Cancer Center, Medical Sciences Campus, University of Puerto Rico, San Juan (M.C.-C.); the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (J.C.F.); Consultants in Gastroenterology, West Columbia, SC (M.E.S.); and the Department of Internal Medicine, University of Iowa Carver College of Medicine, Iowa City (R.W.S.).
出版信息
N Engl J Med. 2015 Oct 15;373(16):1519-30. doi: 10.1056/NEJMoa1500409.
BACKGROUND
Epidemiologic and preclinical data suggest that higher intake and serum levels of vitamin D and higher intake of calcium reduce the risk of colorectal neoplasia. To further study the chemopreventive potential of these nutrients, we conducted a randomized, double-blind, placebo-controlled trial of supplementation with vitamin D, calcium, or both for the prevention of colorectal adenomas.
METHODS
We recruited patients with recently diagnosed adenomas and no known colorectal polyps remaining after complete colonoscopy. We randomly assigned 2259 participants to receive daily vitamin D3 (1000 IU), calcium as carbonate (1200 mg), both, or neither in a partial 2×2 factorial design. Women could elect to receive calcium plus random assignment to vitamin D or placebo. Follow-up colonoscopy was anticipated to be performed 3 or 5 years after the baseline examinations, according to the endoscopist's recommendation. The primary end point was adenomas diagnosed in the interval from randomization through the anticipated surveillance colonoscopy.
RESULTS
Participants who were randomly assigned to receive vitamin D had a mean net increase in serum 25-hydroxyvitamin D levels of 7.83 ng per milliliter, relative to participants given placebo. Overall, 43% of participants had one or more adenomas diagnosed during follow-up. The adjusted risk ratios for recurrent adenomas were 0.99 (95% confidence interval [CI], 0.89 to 1.09) with vitamin D versus no vitamin D, 0.95 (95% CI, 0.85 to 1.06) with calcium versus no calcium, and 0.93 (95% CI, 0.80 to 1.08) with both agents versus neither agent. The findings for advanced adenomas were similar. There were few serious adverse events.
CONCLUSIONS
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 over a period of 3 to 5 years. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00153816.).
背景
流行病学和临床前数据表明，较高的维生素D摄入量和血清水平以及较高的钙摄入量可降低结直肠肿瘤的风险。为了进一步研究这些营养素的化学预防潜力，我们进行了一项随机、双盲、安慰剂对照试验，以补充维生素D、钙或两者来预防结直肠腺瘤。
方法
我们招募了近期诊断为腺瘤且在全结肠镜检查后无已知结直肠息肉残留的患者。我们采用部分2×2析因设计，将2259名参与者随机分配为每日接受维生素D3（1000国际单位）、碳酸钙（1200毫克）、两者或两者都不接受。女性可以选择接受钙并随机分配维生素D或安慰剂。根据内镜医师的建议，预计在基线检查后3年或5年进行随访结肠镜检查。主要终点是从随机分组到预期的监测结肠镜检查期间诊断出的腺瘤。
结果
与给予安慰剂的参与者相比，随机分配接受维生素D的参与者血清25-羟维生素D水平平均净增加7.83纳克/毫升。总体而言，43%的参与者在随访期间被诊断出患有一个或多个腺瘤。维生素D组与无维生素D组复发性腺瘤的校正风险比为0.99（95%置信区间[CI]，0.89至1.09），钙组与无钙组为0.95（95%CI，0.85至1.06），两种药物组与无药物组为0.93（95%CI，0.80至1.08）。晚期腺瘤的结果相似。严重不良事件很少。
结论
在切除结直肠腺瘤后，每日补充维生素D3（1000国际单位）、钙（1200毫克）或两者在3至5年内并未显著降低复发性结直肠腺瘤的风险。（由美国国立癌症研究所资助；ClinicalTrials.gov编号，NCT00153816。）
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