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Efficacy comparison of two doses of vitamin D3 in critically ill patients undergoing continuous renal replacement therapy - NephroD
EU CTIS ID: 2024-510834-42-00
What this study is testing
To evaluate and compare the effect of two different supplementation doses of vitamin D3 (25 (OH) D3) - 500,000 IU and 750,000 IU on the serum concentration of 25 (OH) D3 administered once enterally (througha gastric tuber or orally) in ICU patients with severe vitamin D3 deficiency undergoing continuous renal replacement therapy.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Presence of at least one of the following indications for implementation of CRRT by CVVHDF or CVVHF (Clinical Practice Guideline for Acute Kidney Injury): replacement of non-functioning kidney function when acute kidney injury occurs; hyperkalemia; metabolic acidosis; pulmonary edema; complications of uremia (hemorrhagic diathesis, pericarditis) - hypervolaemia; -Renal function support (control of goiter, acid-base, ion balance)
- Organ failure score (SOFA) of at least 5 at the time of qualification for the study
- Patient age >18 years
- 25(OH)D3 serum concentration ≤12.5 ng/ml - test performed by the local laboratory of the participating hospital
- Properly managed enteral nutrition (through a gastric tuber or orally) at any dose.
You likely can't join if
- Acute or advanced chronic liver failure (estimated by clinical presentation and biochemical markers: serum bilirubin, serum AST and ALT, high AST/ALT serum ratio, glycemia, INR value)
- Sarcoidosis
- Risk of impaired intestinal absorption in critical illness associated with at least one of the mentioned: impaired intestinal motility and delayed gastric emptying, constipation, diarrhea, intestinal hypoperfusion in shock, intoxication with subsequent intestinal edema after fluid resuscitation, changes in the intestinal microbiome.
- Hypercalcemia (total calcium >11 mg/dL or >2,7mmol/L)
- Any parathyroid disease
- KDIGO classification of end-stage renal disease
See the full eligibility criteria
- Presence of at least one of the following indications for implementation of CRRT by CVVHDF or CVVHF (Clinical Practice Guideline for Acute Kidney Injury): replacement of non-functioning kidney function when acute kidney injury occurs; hyperkalemia; metabolic acidosis; pulmonary edema; complications of uremia (hemorrhagic diathesis, pericarditis) - hypervolaemia; -Renal function support (control of goiter, acid-base, ion balance)
- Organ failure score (SOFA) of at least 5 at the time of qualification for the study
- Patient age >18 years
- 25(OH)D3 serum concentration ≤12.5 ng/ml - test performed by the local laboratory of the participating hospital
- Properly managed enteral nutrition (through a gastric tuber or orally) at any dose.
- Acute or advanced chronic liver failure (estimated by clinical presentation and biochemical markers: serum bilirubin, serum AST and ALT, high AST/ALT serum ratio, glycemia, INR value)
- Sarcoidosis
- Risk of impaired intestinal absorption in critical illness associated with at least one of the mentioned: impaired intestinal motility and delayed gastric emptying, constipation, diarrhea, intestinal hypoperfusion in shock, intoxication with subsequent intestinal edema after fluid resuscitation, changes in the intestinal microbiome.
- Hypercalcemia (total calcium >11 mg/dL or >2,7mmol/L)
- Any parathyroid disease
- KDIGO classification of end-stage renal disease
- Patients undergoing plasmapheresis, extracorporeal membrane oxygenation (ECMO), extracorporeal carbon dioxide elimination (ECCO2R)
- Patients who, in the opinion of the investigator, do not have a good chance of surviving the 72 hour period after study entry
- History of kidney stones or de novo renal calculi
- Patient eligible for futile therapy avoidance protocol
- Pregnancy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.