Evidence map›Paper›PMID 23463655›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2013

Randomized clinical trial of vitamin D3 doses on prostatic vitamin D metabolite levels and ki67 labeling in prostate cancer patients.

Dennis Wagner, Dominique Trudel, Theodorus Van der Kwast, Larisa Nonn, Angeline Antonio Giangreco, Doris Li, Andre Dias, Monique Cardoza, Sanda Laszlo, Karen Hersey and 4 more

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 61 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
61citing papers in PubMed, 3 pooled it
6.2field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

61 citing papers in PubMed, 3 syntheses or guidelines pooled it, 98 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
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  6. microRNAs and DICER1 are regulated by 1,25-dihydroxyvitamin D in prostate stroma.The Journal of steroid biochemistry and molecular biology · 2017
    Trial
  7. Trial
  8. Null association between vitamin D and PSA levels among black men in a vitamin D supplementation trial.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2014
    Trial
  9. Trial
  10. Article
  11. Review
  12. The double disparity: Vitamin D deficiency and lethal prostate cancer in black men.The Journal of steroid biochemistry and molecular biology · 2025
    Review
  13. Article
  14. Review
  15. Emerging perspectives: unraveling the anticancer potential of vitamin DNaunyn-Schmiedeberg's archives of pharmacology · 2024
    Review
  16. Review
  17. Review
  18. Article
  19. Article
  20. Article

1 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 2 countries.

Dennis WagnerDepartment of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.
Dominique Trudel
Theodorus Van der Kwast
Larisa Nonn
Angeline Antonio Giangreco
Doris Li
Andre Dias
Monique Cardoza
Sanda Laszlo
Karen Hersey
Laurence Klotz
Antonio Finelli
Neil Fleshner
Reinhold Vieth
University Health Network · CAMount Sinai Hospital · CAUniversity of Illinois Chicago · USUniversity of Toronto · CASunnybrook Health Science Centre · CA

Funding

Significance of Vitamin D-Regulated MicroRNAs in Prostate Cancer PreventionK22CA133105 · NCI · UNIVERSITY OF ILLINOIS AT CHICAGO · PI NONN, LARISA · 2009 to 2011
$498k
CIHRNCI NIH HHS K22 CA133105
6 · The paper itself

Abstract

contextVitamin D3 might benefit prostate cancer (PCa) patients because prostate cells can locally synthesize the active hormone calcitriol.

objectiveOur objective was to determine the effects of oral vitamin D3 on vitamin D metabolites and PCa proliferative activity in prostate tissue. DESIGN AND

settingWe conducted a double-blind randomized clinical trial at surgical oncology clinics in Toronto, Canada. PATIENTS: PCa patients (Gleason 6 or 7) participated in the study. Of 66 subjects who were enrolled, 63 completed the dosing protocol.

interventionVitamin D3 (400, 10 000, or 40 000 IU/d) was orally administered before radical prostatectomy.

main outcome measuresWe evaluated vitamin D metabolite levels and Ki67 labeling in surgical prostate tissue. Safety measures, PTH, and prostate-specific antigen (PSA) were also assessed.

resultsProstate tissue and serum levels of vitamin D metabolites, including calcitriol, increased dose dependently (P < .03) and were significantly higher in the 40 000-IU/d group than in every other dose group (P < .03). Prostate vitamin D metabolites correlated positively with serum levels (P < .0001). Ki67 measures did not differ significantly among vitamin D dose groups. However, cross-sectional analysis indicated that the calcitriol level attained in prostate was inversely associated with Ki67 intensity and Ki67 (3+) percent positive nuclei in PCa and benign tissue (P < .05). Safety measures did not change adversely with dosing. Compared with the 400-IU/d group, serum PTH and PSA were lower in the combined higher-dose groups at the end of the study (P < .02).

conclusionsOral vitamin D3 raised prostate calcitriol levels (level 1 evidence) and modestly lowered both PSA and PTH. Although Ki67 expression did not differ among dose groups, its levels correlated inversely with prostate calcitriol. These suggestions of clinical benefit justify continued clinical research.

Indexed as

AgedCarcinomaCholecalciferolDose-Response Relationship, DrugDouble-Blind MethodHumansKi-67 AntigenMaleMiddle AgedProstatic NeoplasmsStaining and LabelingTissue Array AnalysisValidation Studies as TopicVitamin DCholecalciferolKi-67 AntigenVitamin D

Identifiers

PMID23463655
PMCPMC11651370
OpenAlexW2091214366

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.