A Phase 2 interventional study of Cholecalciferol (2000iu qd) and Routine therapy for PD in Peritoneal Dialysis-associated Peritonitis and Vitamin D Deficiency, sponsored by Peking University First Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-18.
Sponsored by Peking University First Hospital · Phase 2, Interventional, and Prevention
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.
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.
801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.
This study's enrollment of 60 is below the median of 78 across 590 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →Peking University First Hospital is the lead sponsor of 390 studies on the registry; 186 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive oral Cholecalciferol (2000IU qd) apart from routine therapy for PD
Drug: Cholecalciferol (2000iu qd) · Other: Routine therapy for PD
Patients randomized to the placebo group will receive routine therapy for PD.
Other: Routine therapy for PD
Patients will receive oral Cholecalciferol (2000IU qd) apart from routine therapy for PD
Also known as: Natural Vitamin D3
Patients randomized to the placebo group will receive routine therapy for PD.
Recruitment rate of the trial
Recruitment rate of patients screened for the trial measured by percentage.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: From date of randomization until 1 year after the randomization of last participant
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.
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.
Probability of participants who recovered after peritoneal dialysis-related peritonitis measured by percentage.
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.
Risk of participants who died because of peritoneal dialysis-related peritonitis measured by percentage.
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.
Risk of patients who are transferred to hemodialysis because of peritoneal dialysis related peritonitis measured by percentage.
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.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in May 2021, 43 months.
Of 18 phase 2 interventional studies under Vitamin D Deficiency, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 45. This study's 43 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholecalciferol
Peking University First Hospital →