Evidence map›Paper›PMID 34173940›Full record

Trial reportJournal of nephrology2022

Calcifediol supplementation in adults on hemodialysis: a randomized controlled trial.

Luigi Morrone, Suetonia C Palmer, Valeria M Saglimbene, Annalisa Perna, Giuseppe Cianciolo, Domenico Russo, Loreto Gesualdo, Patrizia Natale, Antonio Santoro, Sandro Mazzaferro and 6 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of nephrology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01457001 (Controlled Randomised Interventional Trial on the Use of 25-OH D Vitamin in Haemodialysis Patients.), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 27% 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.

NCT01457001 phase3terminatednot on this map

Controlled Randomised Interventional Trial on the Use of 25-OH D Vitamin in Haemodialysis Patients.

TypeinterventionalSponsorItalian Society of NephrologyRan2012 to 2016Enrolled284ConditionsChronic Renal FailureArms25-OH-D vitamin
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Current Knowledge of the Impact of Vitamin D in Coronary Artery Disease.International journal of molecular sciences · 2025
    Review
  7. The role of nutritional vitamin D in chronic kidney disease-mineral and bone disorder in children and adults with chronic kidney disease, on dialysis, and after kidney transplantation-a European consensus statement.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
    Article
  8. Vitamin D: are all compounds equal?Clinical kidney journal · 2025
    Article
  9. Review
  10. Review
  11. Review
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 12 institutions in 3 countries.

Luigi MorroneStruttura complessa di nefrologia e dialisi ASL Taranto, Taranto, Italy.
Suetonia C PalmerDepartment of Medicine, University of Otago, Christchurch, New Zealand.
Valeria M SaglimbeneFaculty of Medicine and Health, Sydney School of Public Health, University of Sydney, Sydney, Australia.
Annalisa PernaIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Bergamo, Italy.
Giuseppe CiancioloNephrology Dialysis and Kidney Transplantation Unit, IRCCS, Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Domenico RussoUnit of Nephrology and Hypertension, Department of Public Health, University of Naples Federico II, Naples, Italy.
Loreto GesualdoDepartment of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
Patrizia NataleFaculty of Medicine and Health, Sydney School of Public Health, University of Sydney, Sydney, Australia.
Antonio SantoroScuola di Specializzazione in Nefrologia, Policlinico S. Orsola-Malpighi, Università degli Studi di Bologna, Bologna, Italy.
Sandro MazzaferroDipartimento di Nefrologia, Policlinico Umberto I, Università La Sapienza di Roma, Roma, Italy.
Mario CozzolinoStruttura Complessa di Nefrologia e Dialisi ASST Santi Paolo e Carlo, Dipartimento di Scienze della Salute, Università di Milano, Milano, Italy.
Adamasco CupistiDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Marina Di LucaStruttura Complessa di Nefrologia e Dialisi, A.O. Ospedali Riuniti Marche Nord, Pesaro, Italy.
Biagio Di IorioStruttura Complessa di Nefrologia e Dialisi, A.O. "San Giuseppe Moscati", Avellino, Italy.
Giovanni F M StrippoliFaculty of Medicine and Health, Sydney School of Public Health, University of Sydney, Sydney, Australia. gfmstrippoli@gmail.com.
Mineral Metabolism Study Group of the Italian Society of Nephrology
Azienda USL di Bologna · ITIRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · ITMario Negri Institute for Pharmacological Research · ITThe University of Sydney · AUAzienda Ospedaliera S.Giuseppe Moscati · ITOspedale San Paolo · ITOspedali Riuniti Marche Nord · ITPoliclinico Umberto I · ITUniversity of Bari Aldo Moro · ITUniversity of Naples Federico II · ITUniversity of Otago · NZUniversity of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVitamin D deficiency is associated with increased risks of mortality in people with chronic kidney disease. The benefits and harm of vitamin D supplementation on cardiovascular outcomes and mortality are unknown. We aimed to assess the effectiveness of calcifediol in reducing mortality in patients with vitamin D insufficiency on hemodialysis compared to no additional therapy.

methodsA phase III, multicenter, randomized, open-label trial was conducted including 284 adults with vitamin D insufficiency undergoing hemodialysis who were randomly assigned to receive oral calcifediol or standard care for 24 months.

resultsTwo hundred eighty-four participants were enrolled (143 assigned to the calcifediol group and 141 to the no additional therapy group). The primary outcome (mortality) occurred in 34 and 31 participants in the calcifediol and control group, respectively [hazard ratio (HR) 1.03; 95% confidence interval (CI) 0.63-1.67]. Calcifediol had no detectable effects on cardiovascular death (HR 1.06; 95% CI 0.41-2.74), non-cardiovascular death (HR 1.13; 95% CI 0.62-2.04), nonfatal myocardial infarction (HR 0.20; 95% CI 0.02-1.67) or nonfatal stroke (HR could not be estimated). The incidence of hypercalcemia and hyperphosphatemia was similar between groups. None of the participants underwent parathyroidectomy.

conclusionsIn adults treated with hemodialysis and who had vitamin D insufficiency, calcifediol supplementation for 24 months had inconclusive effects on mortality and cardiovascular outcomes. TRIAL REGISTRATION NUMBER: NCT01457001.

Indexed as

CalcifediolVitaminsAdultDietary SupplementsDouble-Blind MethodHumansRenal DialysisCalcifediolVitaminsCalcifediolESKDHemodialysisMortalityVitamin D

Identifiers

PMID34173940
OpenAlexW3175706648

What OpenQuestion holds

Textmetadata
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.