Peritoneal Dialysis-associated PeritonitisPhase 2NCT03264625
The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis
A Phase 2 study testing Cholecalciferol (2000iu qd) and Routine therapy for PD 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 pilot randomized, controlled trial of Vitamin D supplementation in patients on peritoneal dialysis to determine the feasibility of a future full-scale RCT exploring if oral administration of vitamin D3 could reduce the risk of subsequent Peritoneal dialysis-related (PD-related) peritonitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis-associated Peritonitis, Vitamin D Deficiency
- What is being tested?
- Cholecalciferol (2000iu qd) and Routine therapy for PD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2017to 30 Jul 2021
- Phase
- Phase 2
- 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
- Medically stable and receiving peritoneal dialysis (PD) for>1 months
- Age at least 18 years.
- Serum 25(OH)D<75nmol/l (30ng/ml)
- Adequate dialysis on evaluation, weekly Kt/V ≥ 1.5 and no clinical uremic symptoms
Who cannot join
- Receive Vitamin D2/D3 or drugs known to alter serum 25-hydroxyvitamin D (25(OH)D) levels during the previous 12 months;
- History of allergic reaction to Cholecalciferol;
- Current or past malignant disease, active hepatitis or hepatic failure, acute systemic infection, active autoimmune diseases, severe digestive malabsorption or eating disorder, HIV/AIDS;
- A high probability (assessed by the recruiting physician) of receiving a kidney transplant or transferring to hemodialysis (HD) or drop-out due to socioeconomic causes within 6 months;
- Pregnant or breastfeeding;
Trial locations and contacts
1 site in 1 country.
About this study
This is a pilot randomized, controlled trial of Vitamin D supplementation in patients on peritoneal dialysis to determine the feasibility of a future full-scale RCT exploring if oral administration of vitamin D3 could reduce the risk of subsequent Peritoneal dialysis-related (PD-related) peritonitis.
Aims of the study:
Aim 1: To determine the feasibility of oral vitamin D supplementation among PD patients who have recovered from a recent episode of peritonitis.
Aim 2: To examine the effect of vitamin D supplementation on the risk for peritonitis among patients on peritoneal dialysis.
Read the detailed description
Patients will be screened for eligibility one month after the onset of PD-related peritonitis, those who meet the inclusion criteria will be enrolled in this study.
All consenting participants will be randomized into the vitamin D treatment group or the control group, general information and baseline biochemistry data would be collected. Patients in the treatment group will be treated with oral Cholecalciferol (2000IU/day) apart from routine treatment for PD. Those in the control group will receive routine treatment for PD. Both groups will be followed for 12 months. During the observational period, any onset of subsequent peritonitis will be recorded, serum 25(OH)D, biochemical indices will be measured every 3 months. Follow up would take place frequently, any outcome events would be recorded.
Aims and hypotheses:
Aim 1: To determine the feasibility of oral vitamin D supplementation among PD patients who have recovered from a recent episode of peritonitis.
Hypothesis1: A large、full-scale randomized controlled trail on the effects of oral vitamin D on the risk for peritonitis among PD patients is feasible.
Aim 2: To examine the effect of vitamin D supplementation on the risk for peritonitis among patients on peritoneal dialysis.
Hypothesis 2: Oral supplementation of vitamin D will reduce the risk of subsequent peritoneal dialysis.
- Being tested
- Cholecalciferol (2000iu qd), Routine therapy for PD
- Keywords
- Cholecalciferol, Peritoneal dialysis, Peritonitis
- 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.
Cholecalciferol (2000iu qd)Drug
Also called Natural Vitamin D3
Patients will receive oral Cholecalciferol (2000IU qd) apart from routine therapy for PD
Routine therapy for PDOther
Patients randomized to the placebo group will receive routine therapy for PD.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients will receive oral Cholecalciferol (2000IU qd) apart from routine therapy for PD Receives: Drug: Cholecalciferol (2000iu qd); Other: Routine therapy for PD |
| Control group | Placebo comparator | Patients randomized to the placebo group will receive routine therapy for PD. Receives: Other: Routine therapy for PD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate of the trial
Recruitment rate of patients screened for the trial measured by percentage.
Measured: From date of randomization until 1 year after the randomization of last participant.
Retention rate of the trial
Retention rate of included patients in the trial measured by percentage.
Measured: From date of randomization until 1 year after the randomization of last participant
Adherence rate of the trial
Percentage of participants adherent to the dosing regimen of vitamin D in the trial.
Measured: From date of randomization until 1 year after the randomization of last participant.
Incidence of adverse events
Incidence of adverse events measured by number of events per patient-month
Measured: From date of randomization until 1 year after the randomization of last participant.
Change in serum 25(OH)D level
Change in serum 25(OH)D level between baseline and 12 months measured by ng/ml.
Measured: From date of randomization until 1 year after the randomization of last participant
Secondary outcomes (4)
Difference in risk of a subsequent peritonitis measured by Hazard Ratio.
Risk of a subsequent peritoneal dialysis related peritonitis in the interventional group compared with the control group measured by Hazard Ratio.
Measured: From date of randomization until the date of subsequent peritonitis, assessed up to 1 year.
Probability of participants who recovered after subsequent peritoneal dialysis related peritonitis.
Probability of participants who recovered after peritoneal dialysis-related peritonitis measured by percentage.
Measured: From date of randomization until the date of documented death, assessed up to 1 year.
Risk of participants who died because of subsequent peritoneal dialysis related peritonitis.
Risk of participants who died because of peritoneal dialysis-related peritonitis measured by percentage.
Measured: From date of randomization until the date of documented death, assessed up to 1 year.
Risk of participants who are transitioned to hemodialysis because of subsequent peritoneal dialysis related peritonitis.
Risk of patients who are transferred to hemodialysis because of peritoneal dialysis related peritonitis measured by percentage.
Measured: From date of randomization until the date of documented transition to hemodialysis because of peritoneal dialysis related peritonitis, assessed up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start30 Sep 2017
- Primary completion28 May 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Jie, Peking University First Hospital
- Investigators
- Jie Dong, Study director, Peking Universiy First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264625
- Sponsor's protocol ID
- Vitamin D, RCT
- Status last verified
- Aug 2021
- First submitted
- 10 Oct 2016
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pi HC, Ren YP, Wang Q, Xu R, Dong J. Serum 25-Hydroxyvitamin D Level Could Predict the Risk for Peritoneal Dialysis-Associated Peritonitis. Perit Dial Int. 2015 Dec;35(7):729-35. doi: 10.3747/pdi.2014.00177. Epub 2015 Jul 29.
PubMed 26224791Armas LA, Andukuri R, Barger-Lux J, Heaney RP, Lund R. 25-Hydroxyvitamin D response to cholecalciferol supplementation in hemodialysis. Clin J Am Soc Nephrol. 2012 Sep;7(9):1428-34. doi: 10.2215/CJN.12761211. Epub 2012 Jul 12.
PubMed 22798536Zhang YH, Xu X, Pi HC, Yang ZK, Johnson DW, Dong J. The effects of oral vitamin D supplementation on the prevention of peritoneal dialysis-related peritonitis: study protocol for a randomized controlled clinical trial. Trials. 2019 Nov 28;20(1):657. doi: 10.1186/s13063-019-3784-7.
PubMed 31779675
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. 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
- ClinicalTrials.gov ID
- NCT03264625
- Acronym / sponsor ID
- Vitamin D, RCT
- Keywords
- Cholecalciferol, Peritoneal dialysis, Peritonitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 29 Aug 2017 (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 pilot randomized, controlled trial of Vitamin D supplementation in patients on peritoneal dialysis to determine the feasibility of a future full-scale RCT exploring if oral administration of vitamin D3 could reduce the risk of subsequent Peritoneal dialysis-related (PD-related) peritonitis.
Aims of the study:
Aim 1: To determine the feasibility of oral vitamin D supplementation among PD patients who have recovered from a recent episode of peritonitis.
Aim 2: To examine the effect of vitamin D supplementation on the risk for peritonitis among patients on peritoneal dialysis.
Detailed description
Patients will be screened for eligibility one month after the onset of PD-related peritonitis, those who meet the inclusion criteria will be enrolled in this study.
All consenting participants will be randomized into the vitamin D treatment group or the control group, general information and baseline biochemistry data would be collected. Patients in the treatment group will be treated with oral Cholecalciferol (2000IU/day) apart from routine treatment for PD. Those in the control group will receive routine treatment for PD. Both groups will be followed for 12 months. During the observational period, any onset of subsequent peritonitis will be recorded, serum 25(OH)D, biochemical indices will be measured every 3 months. Follow up would take place frequently, any outcome events would be recorded.
Aims and hypotheses:
Aim 1: To determine the feasibility of oral vitamin D supplementation among PD patients who have recovered from a recent episode of peritonitis.
Hypothesis1: A large、full-scale randomized controlled trail on the effects of oral vitamin D on the risk for peritonitis among PD patients is feasible.
Aim 2: To examine the effect of vitamin D supplementation on the risk for peritonitis among patients on peritoneal dialysis.
Hypothesis 2: Oral supplementation of vitamin D will reduce the risk of subsequent peritoneal dialysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Cholecalciferol (2000iu qd), Other: Routine therapy for PDPatients will receive oral Cholecalciferol (2000IU qd) apart from routine therapy for PD |
| Control group | Placebo comparator | Other: Routine therapy for PDPatients randomized to the placebo group will receive routine therapy for PD. |
Who may qualify
- Ages
- 18 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 (PD) for>1 months
- Age at least 18 years.
- Serum 25(OH)D<75nmol/l (30ng/ml)
- Adequate dialysis on evaluation, weekly Kt/V ≥ 1.5 and no clinical uremic symptoms
Key exclusion criteria (5 listed)
- Receive Vitamin D2/D3 or drugs known to alter serum 25-hydroxyvitamin D (25(OH)D) levels during the previous 12 months;
- History of allergic reaction to Cholecalciferol;
- Current or past malignant disease, active hepatitis or hepatic failure, acute systemic infection, active autoimmune diseases, severe digestive malabsorption or eating disorder, HIV/AIDS;
- A high probability (assessed by the recruiting physician) of receiving a kidney transplant or transferring to hemodialysis (HD) or drop-out due to socioeconomic causes within 6 months;
- Pregnant or breastfeeding;
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 |
|---|---|---|
| Cholecalciferol (2000iu qd)Also: Natural Vitamin D3Patients will receive oral Cholecalciferol (2000IU qd) apart from routine therapy for PD | Drug | Treatment group |
| Routine therapy for PDPatients randomized to the placebo group will receive routine therapy for PD. | Other | Control group, Treatment group |
Primary outcome
Recruitment rate of the trial
Time frame: From date of randomization until 1 year after the randomization of last participant.
Recruitment rate of patients screened for the trial measured by percentage.
Retention rate of the trial
Time frame: From date of randomization until 1 year after the randomization of last participant
Retention rate of included patients in the trial measured by percentage.
Adherence rate of the trial
Time frame: From date of randomization until 1 year after the randomization of last participant.
Percentage of participants adherent to the dosing regimen of vitamin D in the trial.
Incidence of adverse events
Time frame: From date of randomization until 1 year after the randomization of last participant.
Incidence of adverse events measured by number of events per patient-month
Change in serum 25(OH)D level
Time frame: From date of randomization until 1 year after the randomization of last participant
Change in serum 25(OH)D level between baseline and 12 months measured by ng/ml.
4 secondary outcomes
Difference in risk of a subsequent peritonitis measured by Hazard Ratio.
Time frame: From date of randomization until the date of subsequent peritonitis, assessed up to 1 year.
Probability of participants who recovered after subsequent peritoneal dialysis related peritonitis.
Time frame: From date of randomization until the date of documented death, assessed up to 1 year.
Risk of participants who died because of subsequent peritoneal dialysis related peritonitis.
Time frame: From date of randomization until the date of documented death, assessed up to 1 year.
Risk of participants who are transitioned to hemodialysis because of subsequent peritoneal dialysis related peritonitis.
Time frame: From date of randomization until the date of documented transition to hemodialysis because of peritoneal dialysis related peritonitis, assessed up to 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Background: PubMed 26224791Pi HC, Ren YP, Wang Q, Xu R, Dong J. Serum 25-Hydroxyvitamin D Level Could Predict the Risk for Peritoneal Dialysis-Associated Peritonitis. Perit Dial Int. 2015 Dec;35(7):729-35. doi: 10.3747/pdi.2014.00177. Epub 2015 Jul 29.
- Background: PubMed 22798536Armas LA, Andukuri R, Barger-Lux J, Heaney RP, Lund R. 25-Hydroxyvitamin D response to cholecalciferol supplementation in hemodialysis. Clin J Am Soc Nephrol. 2012 Sep;7(9):1428-34. doi: 10.2215/CJN.12761211. Epub 2012 Jul 12.
- Derived from this study: PubMed 31779675Zhang YH, Xu X, Pi HC, Yang ZK, Johnson DW, Dong J. The effects of oral vitamin D supplementation on the prevention of peritoneal dialysis-related peritonitis: study protocol for a randomized controlled clinical trial. Trials. 2019 Nov 28;20(1):657. doi: 10.1186/s13063-019-3784-7.
- Individual participant dataSharing planned: No
Related trials for Peritoneal Dialysis-associated Peritonitis
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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 study director
Peking Universiy 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 2 study testing Cholecalciferol (2000iu qd) and Routine therapy for PD 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 5 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: finished, as of the sponsor's last update on 18 Aug 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate of the trial (time frame: From date of randomization until 1 year after the randomization of last participant.). The study lists 5 primary outcomes in all. 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 NCT03264625, which also lists 3 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 18 Aug 2021.