Clinical trial NCT06096558: The Effects of Melatonin on Cardiovascular and Bone Metabolism Markers in Peritoneal Dialysis Patients
Official title: Effects of Melatonin, as a Dietary Supplement, on Glycemic Parameters, Cardiovascular Disease Risk Factors, Bone Metabolism Markers and Quality of Life in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peritoneal Dialysis
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this double-blind randomized clinical trial is to determine the effects of Melatonin on cardiovascular disease risk factors, bone metabolism markers, serum concentrations of advanced glycated end products and quality of life in peritoneal dialysis patients. Forty patients from peritoneal dialysis centers will randomly assign to either Melatonin or placebo group. The patients in Melatonin group will receive 5 mg Melatonin (as 1 tablet) daily for 10 weeks, while the placebo group will receive identical placebo. At the baseline and the end of the study,7 ml blood will be collected from each patient after a 12-14-hours fasting and Serum concentrations of malondialdehyde; high sensitivity c-reactive protein; Soluble intercellular adhesion molecule-1; glucose; pentosidine; carboxy-methyl lysine; Procollagen 1 Intact N-Terminal Propeptide; Tartrate-resistant acid phosphatase 5b; osteoprotegerin; Receptor activator of nuclear factor kappa-Β ligand; Intact parathyroid hormone; triglyceride; total cholesterol; High-density lipoprotein cholesterol; low-density lipoprotein cholesterol; lipoprotein-a; albumin; calcium; phosphorous; and also systolic blood pressure; diastolic blood pressure and questionnaires including quality of life; quality of sleep and depression will be assessed.


Eligibility criteria: Inclusion Criteria:

* Continuous Ambulatory Peritoneal Dialysis for 6 months or more
* Body mass index (BMI) below 35

Exclusion Criteria:

* Infectious diseases (especially peritonitis) and inflammatory diseases Liver diseases
* Past medical history of cancer Receiving glucocorticoid drugs, non-steroidal anti-inflammatory drugs
* Receiving Melatonin supplements

Primary outcomes:
measure: Lp (a)
timeFrame: 10 weeks
measure: MDA
timeFrame: 10 weeks
measure: hs-CRP
timeFrame: 10 weeks
measure: sICAM-1
timeFrame: 10 weeks
measure: glucose
timeFrame: 10 weeks
measure: pentosidine
timeFrame: 10 weeks
measure: carboxy-methyl lysine
timeFrame: 10 weeks
measure: P1NP
timeFrame: 10 weeks
measure: Osteoprotegerin
timeFrame: 10 weeks
measure: TRACP5b
timeFrame: 10 weeks
measure: RANKL
timeFrame: 10 weeks
measure: Systolic blood pressure
timeFrame: 10 weeks
measure: Diastolic blood pressure
timeFrame: 10 weeks
measure: triglyceride
timeFrame: 10 weeks
measure: Total cholesterol
timeFrame: 10 weeks
measure: HDL-C
timeFrame: 10 weeks
measure: LDL-C
timeFrame: 10 weeks
measure: Quality of life index (KDQOL) questionnaire
timeFrame: 10 weeks
measure: the Beck depression test
timeFrame: 10 weeks
measure: Quality of sleep Pittsburgh Sleep Quality Index (PSQI) questionnaire
timeFrame: 10 weeks
Secondary outcomes:
measure: albumin
timeFrame: 10 weeks
measure: calcium
timeFrame: 10 weeks
measure: phosphorous
timeFrame: 10 weeks
measure: iPTH
timeFrame: 10 weeks
Other outcomes:
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