Vitamin D3 DeficiencyPhase 4NephroDNCT05657678
Vitamin D3 Supplementation in Critically Ill Patients Undergoing CRRT
A Phase 4 study testing Vitamin D3 - 750 000 IU and Vitamin D3 - 500 000 IU in people with Vitamin D3 Deficiency, run by Uniwersytecki Szpital Kliniczny w Opolu at 4 sites in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D3 Deficiency
- What is being tested?
- Vitamin D3 - 750 000 IU and Vitamin D3 - 500 000 IU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 4 sitesPoland
- Study dates
- 20 Dec 2022to 1 May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Poland4 sites, 4 recruiting
- Recruiting
5 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
Krakow
Wojciech Szczeklik, MD, PhD
- Recruiting
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin
Pawel Piwowarczyk, MD, PhD
- Recruiting
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Opole Voivodeship, 45-401
Ryszard Gawda, MD, PhD, onetime@wp.pl
Tomasz Czarnik, MD, PhD, tczarnik@mac.com
- Recruiting
Samodzielny Publiczny Szpital Kliniczny nr 1 Śląski Uniwersytet Medyczny w Katowicach
Zabrze, 41-800
Szymon Bialka, MD, PhD
About this study
Official title: Efficacy Comparison of Two Doses of Vitamin D3 in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
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
- Being tested
- Vitamin D3 - 750 000 IU, Vitamin D3 - 500 000 IU
- Keywords
- vitamin D, severe deficiency, continuous renal replacement therapy, intensive care, supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 - 750 000 IUDrug
a single administration of 750,000 IU of vitamin D3
Vitamin D3 - 500 000 IUDrug
a single administration of 500,000 IU of vitamin D3
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Vitamin D3 - 500 000 IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (6)
Mortality
To evaluate and compare the effects of two different supplementation doses of vitamin D3 on mortality in ICU patients undergoing continuous renal replacement therapy
Measured: 90 days
ICU treatment duration
To evaluate and compare the effects of two different supplementation doses of vitamin D3 on ICU treatment duration in patients undergoing continuous renal replacement therapy
Measured: 90 days
SOFA
To evaluate and compare the effects of two different supplementation doses of vitamin D3 on Sequential Organ Failure Assessment (SOFA) scores in ICU patients undergoing continuous renal replacement therapy
Measured: 90 days
Catecholamines
To evaluate and compare the effects of two different supplementation doses of vitamin D3 on the duration of catecholamine administration in ICU patients undergoing continuous renal replacement therapy
Measured: 90 days
CRRT
To evaluate the relationship between the length of CRRT use in hours from the time of study drug administration to the beginning of visit 4 and serum vitamin D3 levels in both study arms
Measured: 7 days
GRV
To assess the relationship between total gastric residual volume (GRV) in millilitres from the time of study drug administration to the date of the beginning of visit 3 and serum vitamin D3 levels in both study arms
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start20 Dec 2022
- Primary completion1 Jan 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D3 DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uniwersytecki Szpital Kliniczny w Opolu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Czarnik, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu
- Investigators
- Tomasz Czarnik, MD, PhD, Principal investigator, Uniwersytecki Szpital Kliniczny w Opolu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657678
- Sponsor's protocol ID
- NephroD_2021
- Acronym
- NephroD
- Status last verified
- Apr 2024
- First submitted
- 12 Dec 2022
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39582029
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Comparison of Two Doses of Vitamin D3 in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT05657678
- Acronym / sponsor ID
- NephroD / NephroD_2021
- Conditions
- Vitamin D3 Deficiency
- Keywords
- vitamin D, severe deficiency, continuous renal replacement therapy, intensive care, supplementation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Uniwersytecki Szpital Kliniczny w OpoluUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Drug: Vitamin D3 - 750 000 IUa 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 |
| Control Arm | Active comparator | Drug: Vitamin D3 - 500 000 IUa 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Presence of the following indications for initiation of CRRT with CVVHDF or CVVHF (acc. to KDIGO, Clinical Practice Guideline for Acute Kidney Injury):
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 - 750 000 IUa single administration of 750,000 IU of vitamin D3 | Drug | Interventional Arm |
| Vitamin D3 - 500 000 IUa single administration of 500,000 IU of vitamin D3 | Drug | Control Arm |
Primary outcome
Supplementation
Time frame: 7 days
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
6 secondary outcomes
Mortality
Time frame: 90 days
ICU treatment duration
Time frame: 90 days
SOFA
Time frame: 90 days
Catecholamines
Time frame: 90 days
CRRT
Time frame: 7 days
GRV
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Derived from this study: PubMed 39582029Czarnik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Czarnik, MD, PhD principal investigator
Uniwersytecki Szpital Kliniczny w Opolu
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D3 - 750 000 IU and Vitamin D3 - 500 000 IU in people with Vitamin D3 Deficiency, run by Uniwersytecki Szpital Kliniczny w Opolu at 4 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomasz Czarnik, MD, PhD (0048669906333, tczarnik@mac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supplementation (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05657678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.