Vitamin D3 supplementation for critically ill patients on kidney support
Efficacy Comparison of Two Doses of Vitamin D3 in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
This study is testing if giving high doses of Vitamin D3 to critically ill patients on kidney support can improve their health and help with Vitamin D3 deficiency.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uniwersytecki Szpital Kliniczny w Opolu Academic / other |
| Locations | 4 sites (Opole, Opolskie and 3 other locations) |
| Trial ID | NCT05657678 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of high-dose Vitamin D3 supplementation in critically ill patients undergoing continuous renal replacement therapy (CRRT). The study aims to address the high prevalence of Vitamin D3 deficiency in ICU patients, which can be exacerbated by their medical conditions and treatments. Participants will receive either 750,000 IU or 500,000 IU of Vitamin D3 to evaluate its impact on their deficiency levels and overall health outcomes. The trial focuses on patients with a SOFA score indicating significant organ dysfunction and low plasma Vitamin D3 levels.
Who should consider this trial
Good fit: Ideal candidates are critically ill patients over 18 years old with a SOFA score of at least 5 and plasma 25(OH)D3 levels of 12.5 ng/ml or lower.
Not a fit: Patients with acute or advanced chronic liver failure or hypercalcaemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the health outcomes of critically ill patients by effectively addressing Vitamin D3 deficiency.
How similar studies have performed: While there is limited data on similar high-dose Vitamin D3 interventions in critically ill patients, the approach is promising and may lead to significant advancements in treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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) 2. Sequential Organ Failure Assessment (SOFA) score of minimum 5 points at enrolment 3. Age of \>18 years 4. Plasma 25(OH)D3 levels ≤12.5 ng/ml as measured by the local laboratory of a participating hospital 5. Properly managed enteral nutrition regardless of dosing Exclusion Criteria: 1. 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) 2. Hypercalcaemia (total calcium concentration \>11 mg/dl) 3. Any parathyroid disorder 4. End stage renal disease according to the KDIGO classification 5. Patients undergoing plasmapheresis, extracorporeal membrane oxygenation (ECMO), extracorporeal carbon dioxide removal (ECCO2R) 6. Patients who, in the opinion of the investigator, are not expected to survive 72 hours since enrolment 7. A history of nephrolithiasis or de novo nephrolithiasis 8. Patient qualified to a protocol for the avoidance of futile therapy 9. Pregnancy 10. Sarcoidosis 11. 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.
Where this trial is running
Opole, Opolskie and 3 other locations
- Uniwersytecki Szpital Kliniczny w Opolu — Opole, Opolskie, 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, Poland (Recruiting)
Study contacts
- Principal investigator: Tomasz Czarnik, MD, PhD — Uniwersytecki Szpital Kliniczny w Opolu
- Study coordinator: Tomasz Czarnik, MD, PhD
- Email: tczarnik@mac.com
- Phone: 0048669906333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.