Vitamin D3 Supplementation in Critically Ill Patients Undergoing CRRT

NCT05657678 | Recruiting Phase 4 DMC

• 1 other identifier: NephroD_2021
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 4

Brief Summary

Patients hospitalized in intensive care units (ICU) are particularly susceptible to vitamin D3 deficiencies. This can be due to the severity of their underlying disease, the type of treatment they are on, malnutrition before and inadequate nutrition during the hospitalisation preceding ICU admission, as well as advanced age. It has also been established that plasma levels of 25(OH)D3 tend to systematically decrease during ICU treatment. Therapeutic interventions administered in ICU settings such as fluid resuscitation or extracorporeal therapies can cause additional vitamin D3 deficiencies. The incidence of deficiency in critically ill patients can reach up to 90%, and even 30% of ICU patients can have undetectable plasma levels. It is impossible to replenish vitamin D3 levels in critically ill patients with traditional enteral and parenteral nutrition treatment regimens, because nutritional products contain too little of the vitamin. Vitamin D3 deficiency in critically ill patients has been associated with acute kidney injury, acute respiratory failure, sepsis, septic shock and increased all-cause ICU mortality. Despite that, assessment of plasma 25(OH)D3 levels is not a routine practice in ICUs. In view of the prevalence of vitamin D3 deficiencies in ICU patients, rapid replenishment of this deficiency with an increased supplementation dose should be considered as a potential means to improve prognosis in this patient population. The current standard therapy is the administration of 500,000 IU of vitamin D3 via the enteral route in ICU patients with severe deficiency (recommended by ESPEN). The NephroD study is meant to help answer the question whether increasing the standard ICU supplementation dose of vitamin D3 by 50% will ensure a more effective replenishment of this vitamin in critically ill patients undergoing CRRT.

Conditions

Vitamin D3 Deficiency

Keywords

vitamin D; severe deficiency; continuous renal replacement therapy; intensive care; supplementation

Outcome Measures

Primary Outcomes (1)

• Supplementation

  To evaluate and compare the effects of two different supplementation doses of vitamin D3 (25(OH)D3) - 500,000 IU or 750,000 IU administered as one enteral dose - on plasma levels of 25(OH)D3 in ICU patients undergoing continuous renal replacement therapy and diagnosed with severe vitamin D3 deficiency

  7 days

Secondary Outcomes (6)

• Mortality

  90 days

• ICU treatment duration

  90 days

• SOFA

  90 days

• Catecholamines

  90 days

• CRRT

  7 days

Study Arms (2)

Interventional Arm

EXPERIMENTAL

a single administration of 750,000 IU of vitamin D3 via the enteral route (through a gastric tube) in ICU patients with severe vitamin D3 deficiency (measured plasma 25(OH)D3 levels ≤12.5 ng/ml) undergoing continuous renal replacement therapy with CVVHDF or CVVHF

Drug: Vitamin D3 - 750 000 IU

Control Arm

ACTIVE COMPARATOR

a single administration of 500,000 IU of vitamin D3 via the enteral route (through a gastric tube) in ICU patients with severe vitamin D3 deficiency (measured plasma 25(OH)D3 levels ≤12.5 ng/ml) undergoing continuous renal replacement therapy with CVVHDF or CVVHF

Drug: Vitamin D3 - 500 000 IU

Interventions

Vitamin D3 - 750 000 IU DRUG

a single administration of 750,000 IU of vitamin D3

Interventional Arm

Vitamin D3 - 500 000 IU DRUG

a single administration of 500,000 IU of vitamin D3

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of the following indications for initiation of CRRT with CVVHDF or CVVHF (acc. to KDIGO, Clinical Practice Guideline for Acute Kidney Injury):
• replacement of kidney function in acute kidney injury
• hyperkalaemia
• metabolic acidosis
• pulmonary oedema
• uraemic complications (bleeding disorder, pericarditis)
• hypervolaemia
• support of renal function (volume control, regulation of acid-base and electrolyte status)
• Sequential Organ Failure Assessment (SOFA) score of minimum 5 points at enrolment
• Age of \>18 years
• Plasma 25(OH)D3 levels ≤12.5 ng/ml as measured by the local laboratory of a participating hospital
• Properly managed enteral nutrition regardless of dosing

You may not qualify if:

• Acute or advanced chronic liver failure (estimated on the basis of the clinical picture and biochemical markers: plasma bilirubin, plasma AST and ALT, high plasma AST/ALT ratio, glycaemia, INR)
• Hypercalcaemia (total calcium concentration \>11 mg/dl)
• Any parathyroid disorder
• End stage renal disease according to the KDIGO classification
• Patients undergoing plasmapheresis, extracorporeal membrane oxygenation (ECMO), extracorporeal carbon dioxide removal (ECCO2R)
• Patients who, in the opinion of the investigator, are not expected to survive 72 hours since enrolment
• A history of nephrolithiasis or de novo nephrolithiasis
• Patient qualified to a protocol for the avoidance of futile therapy
• Pregnancy
• Sarcoidosis
• Risk of impaired intestinal absorption caused by the critical illness, associated with impaired peristalsis and delayed gastric emptying, constipation, diarrhoea, shock-induced intestinal hypoperfusion, hyperhydration with resulting intestinal oedema following fluid resuscitation, intestinal flora disorders.

Sponsors & Collaborators

• Uniwersytecki Szpital Kliniczny w Opolu: lead

Study Sites (4)

Uniwersytecki Szpital Kliniczny w Opolu

Opole, Opole Voivodeship, 45-401, Poland

RECRUITING

5 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

Krakow, Poland

RECRUITING

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

Lublin, Poland

RECRUITING

Samodzielny Publiczny Szpital Kliniczny nr 1 Śląski Uniwersytet Medyczny w Katowicach

Zabrze, 41-800, Poland

RECRUITING

Related Publications (1)

• Czarnik T, Bialka S, Borys M, Czuczwar M, Misiolek H, Piwowarczyk P, Szczeklik W, Wludarczyk A, Gawda R. Comparison of two doses of vitamin D3 in critically ill patients undergoing continuous renal replacement therapy (NephroD): study protocol for a single-blinded, multicenter, parallel group randomized controlled trial. Trials. 2024 Nov 24;25(1):791. doi: 10.1186/s13063-024-08598-5.

  PMID: 39582029 DERIVED

Study Officials

• Tomasz Czarnik, MD, PhD

  Uniwersytecki Szpital Kliniczny w Opolu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomasz Czarnik, MD, PhD

CONTACT

0048669906333; tczarnik@mac.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 20, 2022
• Study Start: December 20, 2022
• Primary Completion: January 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (4)