Clinical trial NCT03264625: The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis
Official title: The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peritoneal Dialysis-associated Peritonitis
Vitamin D Deficiency
Keywords: Cholecalciferol
Peritoneal dialysis
Peritonitis
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Medically stable and receiving peritoneal dialysis (PD) for\>1 months
2. Age at least 18 years.
3. Serum 25(OH)D\<75nmol/l (30ng/ml)
4. Adequate dialysis on evaluation, weekly Kt/V ≥ 1.5 and no clinical uremic symptoms

Exclusion Criteria:

1. Receive Vitamin D2/D3 or drugs known to alter serum 25-hydroxyvitamin D (25(OH)D) levels during the previous 12 months;
2. History of allergic reaction to Cholecalciferol;
3. Current or past malignant disease, active hepatitis or hepatic failure, acute systemic infection, active autoimmune diseases, severe digestive malabsorption or eating disorder, HIV/AIDS;
4. 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;
5. Pregnant or breastfeeding;

Primary outcomes:
measure: Recruitment rate of the trial
timeFrame: From date of randomization until 1 year after the randomization of last participant.
measure: Retention rate of the trial
timeFrame: From date of randomization until 1 year after the randomization of last participant
measure: Adherence rate of the trial
timeFrame: From date of randomization until 1 year after the randomization of last participant.
measure: Incidence of adverse events
timeFrame: From date of randomization until 1 year after the randomization of last participant.
measure: Change in serum 25(OH)D level
timeFrame: From date of randomization until 1 year after the randomization of last participant
Secondary outcomes:
measure: Difference in risk of a subsequent peritonitis measured by Hazard Ratio.
timeFrame: From date of randomization until the date of subsequent peritonitis, assessed up to 1 year.
measure: Probability of participants who recovered after subsequent peritoneal dialysis related peritonitis.
timeFrame: From date of randomization until the date of documented death, assessed up to 1 year.
measure: Risk of participants who died because of subsequent peritoneal dialysis related peritonitis.
timeFrame: From date of randomization until the date of documented death, assessed up to 1 year.
measure: Risk of participants who are transitioned to hemodialysis because of subsequent peritoneal dialysis related peritonitis.
timeFrame: From date of randomization until the date of documented transition to hemodialysis because of peritoneal dialysis related peritonitis, assessed up to 1 year.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
affiliation: Peking Universiy First Hospital
name: Jie Dong
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Armas 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.
citation: Zhang 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.