Vitamin D Deficiency Due to Chronic Kidney DiseaseNCT06571344
Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management
An observational study of Vitamin D Deficiency Due to Chronic Kidney Disease, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The goal of this observational study is to learn about the effects of cholecalciferol administration, according to guidelines for the general population, on laboratory parameters of Chronic Kidney Disease-Mineral and Bone Disorder in dialysis patients, depending of the attained levels of vitamin D (25OH)D). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency Due to Chronic Kidney Disease
- What is being tested?
- Cholecalciferol
- How many people
- 160 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients will be recruited in Department of Nephrology Transplantology and Internal Medicine, Medical University of Gdansk
Who may be able to join
- CKD stage 5,dialysed patients with vitamin D deficiency or insufficiency (level of 25(OH)D < 30 ng/mL)
Who cannot join
- dialysis time of less than 3 months
- inadequately controled secondary hyperparathyroidism (iPTH>800pg/mL)
- treatment with calcimimetics
- treatment with active forms of vitamin D3,
- parathyroidectomy
- bilateral nephrectomy
- treatment with corticosteroids
- lack of consent to take part in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Agnieszka Tarasewicz, MD; PhD contact
Poland1 site, 1 recruiting
- Recruiting
Medical University of Gdansk
Gdansk, 80-211
Tylcki Leszek, Prof., +48 58 584 47 07, leszek.tylicki@gumed.edu.pl
Agnieszka Tarasewicz, Md, PhD, +48 58 584 47 07, ataras@gumed.edu.pl
About this study
The goal of this observational study is to learn about the effects of cholecalciferol administration, according to guidelines for the general population, on laboratory parameters of Chronic Kidney Disease-Mineral and Bone Disorder in dialysis patients, depending of the attained levels of vitamin D (25OH)D).
The main question it aims to answer is:
How does cholecalciferol affect calcium and phosphate metabolism parameters depending on the achieved levels of 25(OH)D?
Participants taking cholecalciferol as part of their regular medical care for CKD-MBD will have the laboratory result parameters observed for up to 4 years.
Read the detailed description
The analysis will involve data obtained from medical records of dialysis patients who receive standard procedures consistent with national and international guidelines for specialized care.
Specifically, we will analyze the levels of:
- 25(OH)D,
- 1,25(OH)2D
- Calcium
- Phosphates
- PTH
- FGF23
- GDF15 to assess the efficacy and safety of cholecalciferol in dialysis patients.
- Being tested
- Cholecalciferol
- Keywords
- vitamin D, cholecalciferol, 25-hydroxycholecalciferol, parathyroid hormone, FGF23, GDF15, chronic kidney disease-mineral and bone disorder, dialysis
- Medical subject headings
- Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
The patients with vitamin D (25(OH)D) levels < 30 ng/mL, and 30-50 ng/ml will recieve a dose of cholecalciferol at 70,000 IU per week (20,000 IU + 20,000 IU + 30,000 IU per week).
In the patients with 25(OH)D levels 50-80 ng/mL the dose of cholecalciferol will be adjusted to avoid exceeding the upper limit of the laboratory norm.
| Study group | Role | What they receive |
|---|---|---|
| 25(OH)D < 30 ng/mL | Dialysed patients with vitamin D level (25(OH)D) < 30 ng/mL administered cholecalciferol Receives: Drug: Cholecalciferol | |
| 25(OH)D 30 - 49.9 ng/mL | Dialysed patients with vitamin D level (25(OH)D) 30-49.9 ng/mL administered cholecalciferol Receives: Drug: Cholecalciferol | |
| 25(OH)D 50-80 ng/mL | Dialysed patients with vitamin D level (25(OH)D) 50-80 ng/mL administered cholecalciferol Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy and safety of cholecalciferol therapy in dialysed patients
analysis of - vitamin D levels - 25(OH)D, 1,25(OH)2D, calcium-phosphate metabolism parameters (serum calcium, phosphate, PTH levels),FGF23, GDF15 levels, in 3 groups of patients achieving different range of 25(OH)D levels
Measured: 2022-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vitamin D Deficiency Due to Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leszek Tylicki, Prof., Principal investigator, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571344
- Sponsor's protocol ID
- NKBBN/783/2022
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pludowski P, Takacs I, Boyanov M, Belaya Z, Diaconu CC, Mokhort T, Zherdova N, Rasa I, Payer J, Pilz S. Clinical Practice in the Prevention, Diagnosis and Treatment of Vitamin D Deficiency: A Central and Eastern European Expert Consensus Statement. Nutrients. 2022 Apr 2;14(7):1483. doi: 10.3390/nu14071483.
PubMed 35406098Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl (2011). 2017 Jul;7(1):1-59. doi: 10.1016/j.kisu.2017.04.001. Epub 2017 Jun 21. No abstract available.
PubMed 30675420
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management
- ClinicalTrials.gov ID
- NCT06571344
- Acronym / sponsor ID
- NKBBN/783/2022
- Keywords
- vitamin D, cholecalciferol, 25-hydroxycholecalciferol, parathyroid hormone, FGF23, GDF15, chronic kidney disease-mineral and bone disorder, dialysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Aug 2024 (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.
The goal of this observational study is to learn about the effects of cholecalciferol administration, according to guidelines for the general population, on laboratory parameters of Chronic Kidney Disease-Mineral and Bone Disorder in dialysis patients, depending of the attained levels of vitamin D (25OH)D).
The main question it aims to answer is:
How does cholecalciferol affect calcium and phosphate metabolism parameters depending on the achieved levels of 25(OH)D?
Participants taking cholecalciferol as part of their regular medical care for CKD-MBD will have the laboratory result parameters observed for up to 4 years.
Detailed description
The analysis will involve data obtained from medical records of dialysis patients who receive standard procedures consistent with national and international guidelines for specialized care.
Specifically, we will analyze the levels of:
- 25(OH)D,
- 1,25(OH)2D
- Calcium
- Phosphates
- PTH
- FGF23
- GDF15 to assess the efficacy and safety of cholecalciferol in dialysis patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 25(OH)D < 30 ng/mL | – | Drug: CholecalciferolDialysed patients with vitamin D level (25(OH)D) < 30 ng/mL administered cholecalciferol |
| 25(OH)D 30 - 49.9 ng/mL | – | Drug: CholecalciferolDialysed patients with vitamin D level (25(OH)D) 30-49.9 ng/mL administered cholecalciferol |
| 25(OH)D 50-80 ng/mL | – | Drug: CholecalciferolDialysed patients with vitamin D level (25(OH)D) 50-80 ng/mL administered cholecalciferol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited in Department of Nephrology Transplantology and Internal Medicine, Medical University of Gdansk
Key inclusion criteria (1 listed)
- CKD stage 5,dialysed patients with vitamin D deficiency or insufficiency (level of 25(OH)D < 30 ng/mL)
Key exclusion criteria (8 listed)
- dialysis time of less than 3 months
- inadequately controled secondary hyperparathyroidism (iPTH>800pg/mL)
- treatment with calcimimetics
- treatment with active forms of vitamin D3,
- parathyroidectomy
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 |
|---|---|---|
| CholecalciferolThe patients with vitamin D (25(OH)D) levels < 30 ng/mL, and 30-50 ng/ml will recieve a dose of cholecalciferol at 70,000 IU per week (20,000 IU + 20,000 IU + 30,000 IU per week). In the patients with 25(OH)D levels 50-80 ng/mL the dose of cholecalciferol will be adjusted to avoid exceeding the upper limit of the laboratory norm. | Drug | 25(OH)D 30 - 49.9 ng/mL, 25(OH)D 50-80 ng/mL, 25(OH)D < 30 ng/mL |
Primary outcome
efficacy and safety of cholecalciferol therapy in dialysed patients
Time frame: 2022-2026
analysis of - vitamin D levels - 25(OH)D, 1,25(OH)2D, calcium-phosphate metabolism parameters (serum calcium, phosphate, PTH levels),FGF23, GDF15 levels, in 3 groups of patients achieving different range of 25(OH)D levels
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Background: PubMed 35406098Pludowski P, Takacs I, Boyanov M, Belaya Z, Diaconu CC, Mokhort T, Zherdova N, Rasa I, Payer J, Pilz S. Clinical Practice in the Prevention, Diagnosis and Treatment of Vitamin D Deficiency: A Central and Eastern European Expert Consensus Statement. Nutrients. 2022 Apr 2;14(7):1483. doi: 10.3390/nu14071483.
- Background: PubMed 30675420Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl (2011). 2017 Jul;7(1):1-59. doi: 10.1016/j.kisu.2017.04.001. Epub 2017 Jun 21. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for Vitamin D Deficiency Due to Chronic Kidney Disease
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
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.
Agnieszka Tarasewicz, MD; PhD contact
Leszek Tylicki, Prof. principal investigator
Medical University of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency Due to Chronic Kidney Disease, run by Medical University of Gdansk at 1 site 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 1 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leszek Tylicki, Prof. (+ 48 58 584 47 00, leszek.tylicki@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy and safety of cholecalciferol therapy in dialysed patients (time frame: 2022-2026). 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 NCT06571344, which also lists 2 linked publications.
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 26 Aug 2024.