- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02869919
Vitamin D in Critically Ill Patients With Acute Kidney Injury (VID-AKI)
Vitamin D Levels in Critically Ill Patients With Acute Kidney Injury
Panoramica dello studio
Descrizione dettagliata
Vitamin D has an important role in calcium homeostasis and the regulation of bone metabolism. It also appears to play a role in various infectious, immunologic, neurologic, cardiovascular and respiratory disorders. Both, biological and observational studies have identified vitamin D deficiency as a risk factor for adverse outcomes during critical illness. However, administration of high dose vitamin D to a general population of critically ill patients with vitamin D deficiency did not reduce mortality or hospital length of stay. The exception was a pre-defined sub-group of patients with Vitamin D levels in the very low range (<30 nmol/L) where hospital mortality was significantly lower in patients treated with Vitamin D.
Vitamin D Metabolism The majority of vitamin D is produced through the direct action of sunlight on 7-dehydrocholesterol in the skin. The inert Vitamin D3 produced in this manner, together with Vitamin D2 or D3 from dietary sources, require hydroxylation in the liver to 25-hydroxyvitamin D [25(OH)D] which is the main circulating form. Conversion of this still inactive substance to the active form, 1,25-dihydroxyvitamin D [1,25(OH)2D], by the enzyme 1α-hydroxylase occurs primarily, but not exclusively, in the proximal renal tubules. Circulatory phosphorous, parathyroid hormone (PTH) and fibroblast growth factor 23 (FGF23) play an important regulatory role in this process. FGF23 is a bone derived hormone that inhibits renal tubular absorption of phosphate and reduces circulating 1,25(OH)2D. PTH is a hormone secreted by the parathyroid glands in response to hypocalcaemia. It acts to increase the concentration of calcium through several pathways one of which is the upregulation of 1α-hydroxylase, the enzyme responsible for converting 25(OH)D to 1,25(OH)2D.
The majority of both 25(OH)D and 1,25(OH)2D is bound to Vitamin D Binding Protein (VDBP) in circulation. The nuclear Vitamin D Receptors (VDR) which regulate the transcription and expression of Vitamin D targeted genes are only activated by unbound 1,25(OH)2D, which is less than 1% of total circulating Vitamin D.
Vitamin D in chronic kidney disease In patients with chronic kidney disease (CKD) on chronic dialysis, Vitamin D deficiency is common (>80%), and the supplementation with active Vitamin D preparations is strongly recommended to prevent or ameliorate the effects of hyperparathyroid high-turnover bone disease and to reduce the cardiovascular risk.
Vitamin D in general ICU patients ICUs worldwide have reported Vitamin D deficiency ranging from 60-100%. A randomized controlled trial (RCT) in a general population of critically ill patients with vitamin D deficiency showed that administration of high dose vitamin D did not reduce mortality or hospital length of stay. The exception was a pre-defined sub-group of patients with Vitamin D levels in the very low range (<30 nmol/L) in whom hospital mortality was significantly lower in patients treated with Vitamin D. Another RCT investigated the role of 2 different doses of cholecalciferol in 50 critically ill adults with the systemic inflammatory response syndrome. The study showed that prior to randomization 56% of patients were classified as Vitamin D deficient. By day 7 after randomization, Vitamin D levels normalized in >60% of patients and PTH levels decreased over the study period.
Vitamin D and AKI AKI is an abrupt deterioration in kidney function which develops over hours or days for a variety of reasons and can range from mild impairment to acute kidney failure. It affects >50% of critically ill patients worldwide and is independently associated with an increased risk of complications, a longer stay in hospital and high risk of dying. AKI survivors have an increased risk of CKD and premature mortality. A recent study also confirmed a significantly increased risk of bone fractures in patients who survived an episode of AKI requiring renal replacement therapy (RRT).
The causal mechanisms behind the morbidity and mortality associated with AKI are still not fully understood but Vitamin D may play an important role.
The hypothesis of this study is that critically ill patients with AKI have significantly lower Vitamin D levels than critically ill patients without AKI.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Greater London
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London, Greater London, Regno Unito, SE1 7EH
- Guy's & St Thomas Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
age >18 years presence of organ failure
Exclusion Criteria:
Chronic kidney disease stage 3b-5 Renal Transplant Vitamin D deficiency Vitamin D supplementation Hyperparathyroidism Treatment with total parenteral nutrition Life expectancy <48 hours Patients with haemoglobin <70g/L
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Patients with AKI
critically ill patients with acute kidney injury
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Vitamin D levels
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Patients without AKI
critically ill patients without acute kidney injury
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Vitamin D levels
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Vitamin D levels
Lasso di tempo: up to 28 days
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up to 28 days
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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PTH levels
Lasso di tempo: up to 28 days
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up to 28 days
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FGF23 levels
Lasso di tempo: up to 28 days
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up to 28 days
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Marlies Ostermann, PhD, Guy's & St Thomas Hospital
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRAS 196968
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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