Vitamin D3 deficiency MedDRA version: 20.0 Level: PT Classification code 10047626 Term: Vitamin D deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Devikap 15 000 IU/ml, plyn doustny
Product Name: Devikap
Pharmaceutical Form: Oral solution
INN or Proposed INN: Colecalciferol
CAS Number: 67-97-0
Concentration unit: IU/ml international
Sponsors
USK w Opolu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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) 2. organ failure score (SOFA) of at least 5 at the time of qualification for the study 3. patient age >18 years 4. 25(OH)D3 serum concentration =12.5 ng/ml - test performed by the local laboratory of the participating hospital 5. Properly managed enteral nutrition (through a gastric tuber or orally) at any dose. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 138 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 138
Exclusion criteria
Exclusion criteria: 1. 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) 2. hypercalcemia (total calcium >11 mg/dL or >2,7mmol/L ) 3. Any parathyroid disease 4. KDIGO classification of end-stage renal disease 5. Patients undergoing plasmapheresis, extracorporeal membrane oxygenation (ECMO), extracorporeal carbon dioxide elimination (ECCO2R) 6. Patients who, in the opinion of the investigator, do not have a good chance of surviving the 72 hour period after study entry 7. history of kidney stones or de novo renal calculi 8. patient eligible for futile therapy avoidance protocol 9. pregnancy 10. sarcoidosis 11. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 (through a gastric tuber or orally) in ICU patients with severe vitamin D3 deficiency undergoing continuous renal replacement therapy.;Secondary Objective: - Assessment and comparison of the effect of two different doses of vitamin D3 supplementation on: *the mortality in ICU patients undergoing continuous renal replacement therapy, *the duration of ICU treatment in patients undergoing continuous renal replacement therapy, *the sepsis-related organ failure (SOFA) scale in ICU patients undergoing continuous renal replacement therapy, *the duration of catecholamine supply in ICU patients undergoing continuous renal replacement therapy. - To evaluate the correlation between the CRRT duration in hours from the moment of the investigational medicinal product administration until the visit 4 start and the serum vitamin D concentration in both treatment arms. - To evaluate the correlation between total gastric residual volume (GVR) in milliliters from the investigational medicinal product administration until the visit 4 start and the serum vitamin D concentration in both treatment arms. ;Primary end point(s): - Percentage of patients with 25(OH)D3 serum levels =30 ng/mL on days 3 and 7 after vitamin D3 administration.;Timepoint(s) of evaluation of this end point: Will be formally summarized upon completion of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of patients who died on day 28 and day 90 after administration of vitamin D3 preparation. - Duration of treatment in the ICU of patients receiving vitamin D3 preparation. - SOFA score on day 3 and day 7 in patients receiving vitamin D3 preparation. - Duration of catecholamine supply in patients receiving vitamin D3. - The CRRT duration in hours from the investigational medicinal product administration until the visit 4 start. - Total gastric residual volume in milliliters from the investigational medicinal product administration until the visit 3 start. Safety Assessment Endpoints: - Percentage of patients who achieved toxic serum vitamin D3 concentrations (25(OH)D3 =150 ng/mL) on Days 3 and 7. - Percentage of patients who achieved a serum total calcium concentration (>11 mg/dL) on Days 3 and 7.;Timepoint(s) of evaluation of this end point: Will be formally summarized upon completion of the study | — |
Countries
Poland
Contacts
Public ContactTomasz Czarnik
USK w Opolu
Outcome results
None listed