Evidence map›Paper›PMID 23787544›Full record

Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2013

Effects of paricalcitol on calcium and phosphate metabolism and markers of bone health in patients with diabetic nephropathy: results of the VITAL study.

Daniel W Coyne, Dennis L Andress, Michael J Amdahl, Eberhard Ritz, Dick de Zeeuw

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00421733 (VITAL Study - Selective VITamin D Receptor Activator), which is not on this map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
1.9field-weighted citation impact, top 14% 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.

NCT00421733 phase2completednot on this map

VITAL Study - Selective VITamin D Receptor Activator (Paricalcitol) for Albuminuria Lowering Study: A Phase 2, Prospective, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules on Reducing Albuminuria in Type 2 Diabetic Nephropathy Subjects Who Are Currently Being Treated With Renin-angiotensin System Inhibitors

TypeinterventionalSponsorAbbottRan2006 to 2009Enrolled281ConditionsDiabetic Nephropathy, Chronic Kidney DiseaseArmsZemplar (paricalcitol ) capsules, Zemplar (paricalcitol) capsules, Placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Paricalcitol for secondary hyperparathyroidism in renal transplantation.Journal of the American Society of Nephrology : JASN · 2015
    Trial
  6. Article
  7. Vitamin D: are all compounds equal?Clinical kidney journal · 2025
    Article
  8. Article
  9. Article
  10. Article
  11. Observational
  12. The Role of Vitamin D in CKD Stages 3 to 4: Report of a Scientific Workshop Sponsored by the National Kidney Foundation.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2018
    Review
  13. Review
  14. New therapeutic agents in diabetic nephropathy.The Korean journal of internal medicine · 2017
    Review
  15. Role of Vitamin D in Uremic Vascular Calcification.BioMed research international · 2017
    Review
  16. Review
  17. Review
  18. Article
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

5 authors at 5 institutions in 4 countries.

Daniel W CoyneDivision of Renal Diseases, Washington University School of Medicine, St Louis, MO, USA.
Dennis L Andress
Michael J Amdahl
Eberhard Ritz
Dick de Zeeuw
AbbVie (Japan)AbbVie (United States) · USHeidelberg University · DEUniversity Medical Center Groningen · NLWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic kidney disease (CKD) is associated with elevations in serum phosphate, calcium-phosphorus product and bone-specific alkaline phosphatase (BAP), with attendant risks of cardiovascular and bone disorders. Active vitamin D can suppress parathyroid hormone (PTH), but may raise serum calcium and phosphate concentrations. Paricalcitol, a selective vitamin D activator, suppressed PTH in CKD patients (stages 3 and 4) with secondary hyperparathyroidism (SHPT) with minimal changes in calcium and phosphate metabolism.

methodsThe VITAL study enrolled patients with CKD stages 2-4. We examined the effect and relationship of paricalcitol to calcium and phosphate metabolism and bone markers in a post hoc analysis of VITAL. The study comprised patients with diabetic nephropathy enrolled in a double-blind, placebo-controlled, randomized trial of paricalcitol (1 or 2 μg/day). Urinary and serum calcium and phosphate, serum BAP, and intact PTH (iPTH) concentrations were measured throughout the study.

resultsBaseline demographics and calcium, phosphate, PTH (49% with iPTH <70 pg/mL), and BAP concentrations were similar between groups. A transient, modest yet significant increase in phosphate was observed for paricalcitol 2 μg/day (+0.29 mg/dL; P < 0.001). Dose-dependent increases in serum and urinary calcium were observed; however, there were few cases of hypercalcemia: one in the 1-μg/day group (1.1%) and three in the 2-μg/day group (3.2%). Significant reductions in BAP were observed that persisted for 60 days after paricalcitol discontinuation (P < 0.001 for combined paricalcitol groups versus placebo). Paricalcitol dose-dependent reductions in iPTH were observed. Paricalcitol in CKD patients (±SHPT) was associated with modest increases in calcium and phosphate.

conclusionParicalcitol reduces BAP levels, which may be beneficial for reducing vascular calcification.

trial registrationTrial is registered with ClinicalTrials.gov, number NCT00421733.

Indexed as

AgedAlkaline PhosphataseBiomarkersBone and BonesBone Density Conservation AgentsCalciumDiabetic NephropathiesDouble-Blind MethodErgocalciferolsFemaleHumansMaleMiddle AgedParathyroid HormonePhosphatesAlkaline PhosphataseBiomarkersBone Density Conservation AgentsCalciumErgocalciferolsParathyroid HormoneparicalcitolPhosphatesbone-specific alkaline phosphatasecalcitriolhypercalcemiahyperphosphatemiaparicalcitolvitamin D receptor activation

Identifiers

PMID23787544
PMCPMC3769981
OpenAlexW2099772844

What OpenQuestion holds

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LicenceCC BY-NC
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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.