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| Name | Class |
|---|---|
| Peking University Third Hospital | OTHER |
| Peking University People's Hospital | OTHER |
| Beijing Haidian Hospital | OTHER |
| Peking University Shenzhen Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Active Comparator | Patients will be given Cholecalciferol (produced by Xymogen Company) 4000 U (2 capsules) per day |
|
| Control group | Placebo Comparator | Patients will receive placebo, 2 capsules per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | Patients in the intervention group will receive oral cholecalciferol 4000U per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| rate of Systemic infection | Including respiratory infection, gastrointestinal infection, urinary system infection , skin infection etc. | 24 months |
| rate of Technique failure due to peritonitis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Dong, Professor | Contact | 13911841538 | jie.dong@bjmu.edu.cn | |
| Zhikai Yang | Contact | 13671248465 | seapollar@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie Dong | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D010538 | Peritonitis |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| OTHER |
| Beijing Fangshan District Hospital of Traditional Chinese Medicine | UNKNOWN |
| Peking University International Hospital | OTHER |
| Beijing Tsinghua Changgeng Hospital | OTHER |
| Beijing Anzhen Hospital | OTHER |
| Capital Medical University | OTHER |
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.
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Random number will be generated by statistician who is not involved in the study, and will be masked to all participants, caregivers, investigators and outcomes assessors. Only the drug dispensing personnel will have the decoding table. When an eligible patient is enrolled, he/she will be given a sequential patient number, according to block randomization. Such a patient number indicated its group allocation. The drug dispensing personnel will offer the corresponding drug, however with a random drug number. Serial Serum 25- hydroxy-Vitamin D levels, obtained every three months, will be declassified at the end of the study (24 months after enrollment), or till the occurrence of death, permanently transfer to hemodialysis, loss of follow-up, or withdrawal from the study, whichever comes first.
| Placebo | Drug | Patients in the control group will receive placebo 2 capsules per day. |
|
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.
| 24 months |
| rate of Death or transfer to hemodialysis with reasons other than peritonitis | Death or transfer to hemodialysis with reasons other than peritonitis | 24 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |