Calcifediol supplementation in adults on hemodialysis: a randomized controlled trial.
Calcifediol
ESKD
Hemodialysis
Mortality
Vitamin D
Journal
Journal of nephrology
ISSN: 1724-6059
Titre abrégé: J Nephrol
Pays: Italy
ID NLM: 9012268
Informations de publication
Date de publication:
Mar 2022
Mar 2022
Historique:
received:
16
04
2021
accepted:
18
06
2021
pubmed:
27
6
2021
medline:
24
3
2022
entrez:
26
6
2021
Statut:
ppublish
Résumé
Vitamin 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. A 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. Two 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. In adults treated with hemodialysis and who had vitamin D insufficiency, calcifediol supplementation for 24 months had inconclusive effects on mortality and cardiovascular outcomes. NCT01457001.
Sections du résumé
BACKGROUND
BACKGROUND
Vitamin 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.
METHODS
METHODS
A 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.
RESULTS
RESULTS
Two 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.
CONCLUSIONS
CONCLUSIONS
In 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
BACKGROUND
NCT01457001.
Identifiants
pubmed: 34173940
doi: 10.1007/s40620-021-01104-z
pii: 10.1007/s40620-021-01104-z
doi:
Substances chimiques
Vitamins
0
Calcifediol
P6YZ13C99Q
Banques de données
ClinicalTrials.gov
['NCT01457001']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
517-525Investigateurs
Carlo Massimetti
(C)
Fabio Pennacchiotti
(F)
Antonio Mannarino
(A)
Cristina Grimaldi
(C)
Vincenzo Savica
(V)
Onofrio Schillaci
(O)
Olga Credentino
(O)
Maria Domenica Casu
(MD)
Carlo Lomonte
(C)
Valentina Vigo
(V)
Giuseppe Grandaliano
(G)
Stefano Netti
(S)
Filippo Aucella
(F)
Massimo Morosetti
(M)
Roberto Boero
(R)
Francesco Soleti
(F)
Efstratios Fasianos
(E)
Maria Polidoro
(M)
Domenico Santoro
(D)
Alessandra Perna
(A)
Fabio Malberti
(F)
Ludovica d'Apice
(L)
Romano Musacchio
(R)
Maria Carla Porcu
(MC)
Giuseppe Cianciolo
(G)
Silverio Rotondi
(S)
Maria Luisa Muci
(ML)
Informations de copyright
© 2021. Italian Society of Nephrology.
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