Effects of Vitamin D on Dialysis Patients
Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management
This study is testing how taking vitamin D affects bone and mineral health in people on dialysis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Gdansk Academic / other |
| Locations | 1 site (Gdansk) |
| Trial ID | NCT06571344 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how cholecalciferol administration impacts laboratory parameters related to Chronic Kidney Disease-Mineral and Bone Disorder in dialysis patients. By analyzing medical records over a period of up to four years, the study will focus on the effects of vitamin D levels on calcium and phosphate metabolism. Participants will be monitored for changes in various biomarkers, including 25(OH)D, calcium, phosphates, and parathyroid hormone levels, to assess the efficacy and safety of vitamin D supplementation.
Who should consider this trial
Good fit: Ideal candidates for this study are dialysis patients with chronic kidney disease stage 5 who have vitamin D deficiency or insufficiency.
Not a fit: Patients who have been on dialysis for less than three months or those with inadequately controlled secondary hyperparathyroidism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of vitamin D deficiency in dialysis patients, potentially enhancing their overall health outcomes.
How similar studies have performed: While there have been studies on vitamin D supplementation in various populations, this specific approach in dialysis patients is less explored, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * CKD stage 5,dialysed patients with vitamin D deficiency or insufficiency (level of 25(OH)D \< 30 ng/mL) Exclusion Criteria: * 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.
Where this trial is running
Gdansk
- Medical University of Gdansk — Gdansk, Poland (Recruiting)
Study contacts
- Principal investigator: Leszek Tylicki, Prof. — Medical University of Gdansk
- Study coordinator: Leszek Tylicki, Prof.
- Email: leszek.tylicki@gumed.edu.pl
- Phone: + 48 58 584 47 00
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.