Evidence map›Paper›PMID 28835228›Full record

Trial reportBMC cancer2017

Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial.

J De Smedt, S Van Kelst, V Boecxstaens, M Stas, K Bogaerts, D Vanderschueren, C Aura, K Vandenberghe, D Lambrechts, P Wolter and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01748448 (Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 12% 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.

NCT01748448 phase3completednot on this map

Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

TypeinterventionalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2012 to 2022Enrolled436ConditionsCutaneous Malignant MelanomaArmsVitamin D, Placebo: Oil
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Article
  8. Primary Cutaneous Melanoma-Management in 2024.Journal of clinical medicine · 2024
    Article
  9. Article
  10. Observational
  11. Review
  12. Review
  13. Review
  14. Review
  15. Article
  16. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 7 institutions in 2 countries.

J De SmedtLaboratory of Dermatology, Department of oncology, KU Leuven, 3000, Leuven, Belgium. julie.desmedt@uzleuven.be.
S Van KelstLaboratory of Dermatology, Department of oncology, KU Leuven, 3000, Leuven, Belgium.
V BoecxstaensOncological and vascular access surgery, Department of surgical oncology, University Hospitals Leuven, 3000, Leuven, Belgium.
M StasOncological and vascular access surgery, Department of surgical oncology, University Hospitals Leuven, 3000, Leuven, Belgium.
K BogaertsKU Leuven, Faculty of Medicine, I-BioStat, 3000, Leuven, Belgium.
D VanderschuerenClinical and Experimental Endocrinology, Department of Clinical and Experimental Medicine, KU Leuven, 3000, Leuven, Belgium.
C AuraTranslational Cell & Tissue Research, Department of Imaging & Pathology, KU Leuven, 3000, Leuven, Belgium.
K VandenbergheDepartment of Cardiovascular Sciences, KU Leuven, 3000, Leuven, Belgium.
D LambrechtsLaboratory for Translational Genetics, Department of Oncology, KU Leuven, 3000, Leuven, Belgium.
P WolterDepartment of Hematology and Oncology, CHR Verviers East Belgium, 4800, Verviers, Belgium.
O BechterLaboratory of Experimental Oncology (LEO), Department of Oncology, KU Leuven, 3000, Leuven, Belgium.
A NikkelsDepartment of Dermatology, CHU Sart Tilman, University of Liège, 4000, Liège, Belgium.
T StrobbeDepartment of Dermatology, University Hospital Antwerp, 2650, Edegem, Belgium.
G EmriDepartment of Dermatology, Faculty of Medicine, University of Debrecen, Debrecen, 4012, Hungary.
V MarasiganLaboratory of Dermatology, Department of oncology, KU Leuven, 3000, Leuven, Belgium.
M GarmynLaboratory of Dermatology, Department of oncology, KU Leuven, 3000, Leuven, Belgium.
KU Leuven · BEAntwerp University Hospital · BECHR Verviers · BEHasselt University · BERega Institute for Medical Research · BEUniversity of Debrecen · HUUniversity of Liège · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrevious studies have investigated the protective effect of vitamin D serum levels, at diagnosis and during the follow-up period after treatment, on melanoma outcome. In the present study we assess whether vitamin D supplementation, in the follow-up period after diagnosis and surgical resection of the primary tumor, has a protective effect on relapse of cutaneous malignant melanoma and whether this protective effect correlates with vitamin D levels in serum and Vitamin D Receptor immunoreactivity in the primary tumor. METHODS/

designThis study is a multicenter randomized double blind placebo- controlled phase III trial. Patients between the age of 18 and 80 years diagnosed and treated surgically for a melanoma stage IB-III are eligible for randomization in a 1:1 ratio to active treatment or placebo. The study drug is taken each month and consists of either 100,000 International Unit cholecalciferol or arachidis oleum raffinatum used as a placebo. The primary endpoint is relapse free survival. The secondary endpoints are 25 hydroxyvitamin D3 serum levels at diagnosis and at 6 month intervals, melanoma subtype, melanoma site and stage of melanoma at diagnosis according to the 2009 American Joint Committee on Cancer melanoma staging and classification. At randomization a bloodsample is taken for DNA analysis. The study is approved by the local Ethics Committees. DISCUSSION: If we can confirm our hypothesis that vitamin D supplementation after removal of the tumor has a protective effect on relapse of cutaneous malignant melanoma we may reduce the burden of CMM at several levels. Patients, diagnosed with melanoma may have a better clinical outcome and improved quality of life. There will be a decrease in health care costs related to treatment of metastatic disease and there will be a decrease in loss of professional years, which will markedly reduce the economic burden of the disease.

trial registrationClinical Trial.gov, NCT01748448 , 05/12/2012.

Indexed as

Clinical ProtocolsDietary SupplementsVitamin DAdolescentAdultAgedAged, 80 and overBelgiumCalcifediolCutaneous Malignant MelanomaDisease ProgressionFemaleHealth Knowledge, Attitudes, PracticeHumansMaleMelanomaCalcifediolReceptors, CalcitriolVitamin DMelanomaRandomized controlled trialSafetySecondary preventionVitamin D

Identifiers

PMID28835228
PMCPMC5569491
OpenAlexW2749195784

What OpenQuestion holds

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LicenceCC BY
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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.