The Effects of Melatonin on Cardiovascular and Bone Metabolism Markers in Peritoneal Dialysis Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Peritoneal Dialysis

Intervention / Treatment
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* Dietary Supplement: Melatonin
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Melatonin<br> | Dietary Supplement: Melatonin<br>* 5 mg Melatonin in one tablet, 30 minutes before night sleep<br>|
| Placebo Comparator: placebo<br> | Other: placebo<br>* 1 tablet of placebo (starch)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lp (a) | Serum concentrations of lipoprotein-a | 10 weeks | 
| MDA | Serum concentrations of malondialdehyde | 10 weeks | 
| hs-CRP | Serum concentrations of high sensitivity c-reactive protein | 10 weeks | 
| sICAM-1 | Serum concentrations of Soluble intercellular adhesion molecule-1 | 10 weeks | 
| glucose | serum concentration of fasting glucose | 10 weeks | 
| pentosidine | serum concentration of pentosidine | 10 weeks | 
| carboxy-methyl lysine | serum concentration of carboxy-methyl lysine | 10 weeks | 
| P1NP | serum concentration of Procollagen 1 Intact N-Terminal Propeptide | 10 weeks | 
| Osteoprotegerin | Serum concentrations of Osteoprotegerin | 10 weeks | 
| TRACP5b | Serum concentrations of Tartrate-resistant acid phosphatase 5b | 10 weeks | 
| RANKL | Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand | 10 weeks | 
| Systolic blood pressure | Systolic blood pressure (mmHg) | 10 weeks | 
| Diastolic blood pressure | Diastolic blood pressure (mmHg) | 10 weeks | 
| triglyceride | Serum concentrations of triglyceride | 10 weeks | 
| Total cholesterol | Serum concentrations of total cholesterol | 10 weeks | 
| HDL-C | Serum concentrations of High-density lipoprotein cholesterol | 10 weeks | 
| LDL-C | Serum concentrations of low-density lipoprotein cholesterol | 10 weeks | 
| Quality of life index (KDQOL) questionnaire | Filling the kidney disease quality of life index (KDQOL) questionnaire | 10 weeks | 
| the Beck depression test | Filling the Beck depression test | 10 weeks | 
| Quality of sleep Pittsburgh Sleep Quality Index (PSQI) questionnaire | Filling the Pittsburgh Sleep Quality Index (PSQI) questionnaire | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| albumin | Serum concentrations of albumin | 10 weeks | 
| calcium | Serum concentrations of calcium | 10 weeks | 
| phosphorous | Serum concentrations of phosphorous | 10 weeks | 
| iPTH | Serum concentrations of Intact parathyroid hormone | 10 weeks |