Evidence map›Paper›PMID 26465985›Full record

Trial reportThe New England journal of medicine2015

A Trial of Calcium and Vitamin D for the Prevention of Colorectal Adenomas.

John A Baron, Elizabeth L Barry, Leila A Mott, Judy R Rees, Robert S Sandler, Dale C Snover, Roberd M Bostick, Anastasia Ivanova, Bernard F Cole, Dennis J Ahnen and 13 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00153816 (Vitamin D/Calcium Polyp Prevention Study), which is not on this map. Cited by 165 papers, 26 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
165citing papers in PubMed, 26 pooled it
27.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00153816 phase2 / phase3completednot on this map

Vitamin D/Calcium Polyp Prevention Study

TypeinterventionalSponsorDartmouth-Hitchcock Medical CenterRan2004 to 2016Enrolled2,813ConditionsColorectal Cancer, Polyps, AdenomasArmsCalcium Carbonate, Vitamin D3, placebo
3 · Its place in the literature

Who cites it

165 citing papers in PubMed, 26 syntheses or guidelines pooled it, 317 citations in OpenAlex.

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  5. Efficacy of vitamin DAgeing research reviews · 2023
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  17. Guideline
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105 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 15 institutions in 2 countries.

John A BaronFrom 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.).
Elizabeth L Barry
Leila A Mott
Judy R Rees
Robert S Sandler
Dale C Snover
Roberd M Bostick
Anastasia Ivanova
Bernard F Cole
Dennis J Ahnen
Gerald J Beck
Robert S Bresalier
Carol A Burke
Timothy R Church
Marcia Cruz-Correa
Jane C Figueiredo
Michael Goodman
Adam S Kim
Douglas J Robertson
Richard Rothstein
Aasma Shaukat
March E Seabrook
Robert W Summers
Cleveland Clinic · USEmory University · USDartmouth College · USFairview Southdale Hospital · USMinneapolis VA Medical Center · USMinnesota Department of Health · USMinnesota Gastroenterology · USRheumatology Consultants · USThe University of Texas MD Anderson Cancer Center · USUniversity of Iowa · USUniversity of North Carolina at Chapel Hill · USUniversity of Puerto Rico, Medical Sciences Campus · PRUniversity of Southern California · USUniversity of Vermont · USWhite River Junction VA Medical Center · US

Funding

Translational Engineering in Cancer (TEC)P30CA023108 · NCI · DARTMOUTH COLLEGE · PI Fred W Kolling IV · 1985 to 2026
$91.3M
Colorectal Chemoprevention with Calcium and Vitamin DR01CA098286 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BARON, JOHN ANTHONY · 2003 to 2015
$43.9M
Tissue Analysis & Molecular Imaging CoreP30DK056338 · NIDDK · BAYLOR COLLEGE OF MEDICINE · PI James Versalovic · 2001 to 2026
$28.3M
NCI NIH HHS CA098286NCI NIH HHS P30 CA023108NCI NIH HHS R01 CA098286NIDDK NIH HHS P30 DK056338
6 · The paper itself

Abstract

backgroundEpidemiologic 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.

methodsWe 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.

resultsParticipants 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.

conclusionsDaily 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.).

Indexed as

Dietary SupplementsAdenomaAgedCalciumColorectal NeoplasmsDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMiddle AgedRiskTreatment FailureVitamin DVitamins25-hydroxyvitamin DCalciumVitamin DVitamins

Identifiers

PMID26465985
PMCPMC4643064
OpenAlexW2259846353

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.