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New treatment option for Peritoneal Dialysis-associated Peritonitis
Official title Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis
ClinicalTrials.gov ID: NCT05860270
What this study is testing
What is Cholecalciferol?
Cholecalciferol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for peritoneal dialysis-associated peritonitis.
Also referred to as Natural Vitamin D3.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter randomized, placebo-controlled trial of Vitamin D supplementation in patients on peritoneal dialysis to determine whether oral administration of vitamin D3 after curing an episode of peritonitis could reduce the risk of subsequent peritoneal dialysis-related peritonitis.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Medically stable and receiving peritoneal dialysis for \> 1 month
- Older than 18 years old
- Serum 25(OH)D \< 30ng/ml
- Adequate dialysis on evaluation with weekly Kt/V ≥ 1.5, or (revised time: 2023-7-11) without clinical uremic symptoms
You likely can't join if
- Receive Vitamin D2/D3 during the previous 1 month (revised time: 2023-7-11) ;
- History of allergic reaction to Cholecalciferol;
- Current or past malignant disease, active hepatitis or hepatic failure, active autoimmune disease, severe digestive malabsorption or an eating...
- Acute systemic infection, cardiovascular disease, surgery, or trauma in the last month;
- A high probability of receiving a kidney transplant or transferring to hemodialysis or drop-out due to socioeconomic causes within 6 months;
- History of kidney transplant;
See the full eligibility criteria
- Medically stable and receiving peritoneal dialysis for \> 1 month
- Older than 18 years old
- Serum 25(OH)D \< 30ng/ml
- Adequate dialysis on evaluation with weekly Kt/V ≥ 1.5, or (revised time: 2023-7-11) without clinical uremic symptoms
- Receive Vitamin D2/D3 during the previous 1 month (revised time: 2023-7-11) ;
- History of allergic reaction to Cholecalciferol;
- Current or past malignant disease, active hepatitis or hepatic failure, active autoimmune disease, severe digestive malabsorption or an eating disorder, HIV/AIDS;
- Acute systemic infection, cardiovascular disease, surgery, or trauma in the last month;
- A high probability of receiving a kidney transplant or transferring to hemodialysis or drop-out due to socioeconomic causes within 6 months;
- History of kidney transplant;
- Hemodialysis combined with peritoneal dialysis currently;
- Pregnant or breastfeeding;
- Not suitable enrolled assessed by researchers, including patients who could not regular follow-up
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.