Peritoneal Dialysis-associated PeritonitisPhase 4VD-PDNCT05860270
Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis
A Phase 4 study testing Cholecalciferol in people with Peritoneal Dialysis-associated Peritonitis and Vitamin D Deficiency, run by Peking University First Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Peritoneal Dialysis-associated Peritonitis, Vitamin D Deficiency
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2023to 31 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- Hemodialysis combined with peritoneal dialysis currently;
- Pregnant or breastfeeding;
- Not suitable enrolled assessed by researchers, including patients who could not regular follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Jie Dong, 010-83572532, jie.dong@bjmu.edu.cn
About this study
Official title: The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis, a Multicenter Randomized Controlled Trial
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.
Read the detailed description
176 eligible patients on PD at one month after being cured from an episode of peritonitis will be enrolled and randomized into two groups, including the intervention group administered Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day, and the control group administered placebo 2 capsules per day. All participants will be followed for 24 months, or till the occurrence of death, permanently transfer to hemodialysis, loss of follow-up, or withdrawal from the study, whichever comes first. The primary outcome is the occurrence of subsequent peritonitis. The study aims to identify whether oral administration of vitamin D3 after curing an episode of peritonitis could reduce the risk of subsequent peritoneal dialysis-related peritonitis.
- Being tested
- Cholecalciferol, Placebo
- Keywords
- Peritoneal dialysis, Peritonitis, Cholecalciferol
- Medical subject headings
- Vitamin D Deficiency, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Natural Vitamin D3
Patients in the intervention group will receive oral cholecalciferol 4000U per day.
PlaceboDrug
Patients in the control group will receive placebo 2 capsules per day.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | Patients will be given Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day Receives: Drug: Cholecalciferol |
| Control group | Placebo comparator | Patients will receive placebo, 2 capsules per day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hazard Ratio of Subsequent peritonitis
Risk of a subsequent episode of peritoneal dialysis related peritonitis in the interventional group compared with the control group measured by Hazard Ratio.
Measured: 24 months
Secondary outcomes (3)
rate of Systemic infection
Including respiratory infection, gastrointestinal infection, urinary system infection , skin infection etc.
Measured: 24 months
rate of Technique failure due to peritonitis
Including peritonitis associated death (death within 30 days after peritonitis or death during hospitalization due to peritonitis), and transfer to hemodialysis due to uncured peritonitis.
Measured: 24 months
rate of Death or transfer to hemodialysis with reasons other than peritonitis
Death or transfer to hemodialysis with reasons other than peritonitis
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start15 Jun 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis-associated PeritonitisStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients on PD at one month after being cured from an episode of peritonitis will be enrolled and randomized 1:1 into two groups, includingthe intervention group administered Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day, and the control group administered placebo 2 capsules per day.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, Peking University People's Hospital, Beijing Haidian Hospital, Peking University Shenzhen Hospital, Beijing Fangshan District Hospital of Traditional Chinese Medicine, Peking University International Hospital, Beijing Tsinghua Changgeng Hospital, Beijing Anzhen Hospital, Capital Medical University
- Responsible party
- Principal investigator, Dong Jie, Peking University First Hospital
- Investigators
- Jie Dong, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860270
- Sponsor's protocol ID
- Vitamin D and Peritonitis
- Acronym
- VD-PD
- Status last verified
- Aug 2024
- First submitted
- 14 Apr 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis, a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05860270
- Acronym / sponsor ID
- VD-PD / Vitamin D and Peritonitis
- Keywords
- Peritoneal dialysis, Peritonitis, Cholecalciferol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, Peking University People's Hospital, Beijing Haidian Hospital, Peking University Shenzhen Hospital, Beijing Fangshan District Hospital of Traditional Chinese Medicine, Peking University International Hospital, Beijing Tsinghua Changgeng Hospital, Beijing Anzhen Hospital, Capital Medical University
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 16 May 2023 (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.
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.
Detailed description
176 eligible patients on PD at one month after being cured from an episode of peritonitis will be enrolled and randomized into two groups, including the intervention group administered Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day, and the control group administered placebo 2 capsules per day. All participants will be followed for 24 months, or till the occurrence of death, permanently transfer to hemodialysis, loss of follow-up, or withdrawal from the study, whichever comes first. The primary outcome is the occurrence of subsequent peritonitis. The study aims to identify whether oral administration of vitamin D3 after curing an episode of peritonitis could reduce the risk of subsequent peritoneal dialysis-related peritonitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible patients on PD at one month after being cured from an episode of peritonitis will be enrolled and randomized 1:1 into two groups, includingthe intervention group administered Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day, and the control group administered placebo 2 capsules per day.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Drug: CholecalciferolPatients will be given Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day |
| Control group | Placebo comparator | Drug: PlaceboPatients will receive placebo, 2 capsules per day. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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;
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 |
|---|---|---|
| CholecalciferolAlso: Natural Vitamin D3Patients in the intervention group will receive oral cholecalciferol 4000U per day. | Drug | Treatment group |
| PlaceboPatients in the control group will receive placebo 2 capsules per day. | Drug | Control group |
Primary outcome
Hazard Ratio of Subsequent peritonitis
Time frame: 24 months
Risk of a subsequent episode of peritoneal dialysis related peritonitis in the interventional group compared with the control group measured by Hazard Ratio.
3 secondary outcomes
rate of Systemic infection
Time frame: 24 months
rate of Technique failure due to peritonitis
Time frame: 24 months
rate of Death or transfer to hemodialysis with reasons other than peritonitis
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Peritoneal Dialysis-associated Peritonitis
RecruitingObservational study
Peritoneal Dialysis Registration System (PERSIST)
ESRD, Disorders Associated With Peritoneal Dialysis
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.
Jie Dong principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cholecalciferol in people with Peritoneal Dialysis-associated Peritonitis and Vitamin D Deficiency, run by Peking University First Hospital at 1 site in China.
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 4 inclusion and 9 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 6 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 China. 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. Some participants in this study may receive a placebo. 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 Jie Dong, Professor (13911841538, jie.dong@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hazard Ratio of Subsequent peritonitis (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2024.