The Effects of Melatonin on Cardiovascular and Bone Metabolism Markers in Peritoneal Dialysis Patients
- Conditions
- Peritoneal Dialysis
- Interventions
- Dietary Supplement: MelatoninOther: placebo
- Registration Number
- NCT06096558
- Lead Sponsor
- National Nutrition and Food Technology Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 46
- Continuous Ambulatory Peritoneal Dialysis for 6 months or more
- Body mass index (BMI) below 35
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Melatonin Melatonin - placebo placebo -
- Primary Outcome Measures
Name Time Method pentosidine 10 weeks serum concentration of pentosidine
P1NP 10 weeks serum concentration of Procollagen 1 Intact N-Terminal Propeptide
TRACP5b 10 weeks Serum concentrations of Tartrate-resistant acid phosphatase 5b
sICAM-1 10 weeks Serum concentrations of Soluble intercellular adhesion molecule-1
carboxy-methyl lysine 10 weeks serum concentration of carboxy-methyl lysine
Osteoprotegerin 10 weeks Serum concentrations of Osteoprotegerin
LDL-C 10 weeks Serum concentrations of low-density lipoprotein cholesterol
the Beck depression test 10 weeks Filling the Beck depression test
Lp (a) 10 weeks Serum concentrations of lipoprotein-a
Diastolic blood pressure 10 weeks Diastolic blood pressure (mmHg)
Total cholesterol 10 weeks Serum concentrations of total cholesterol
MDA 10 weeks Serum concentrations of malondialdehyde
hs-CRP 10 weeks Serum concentrations of high sensitivity c-reactive protein
triglyceride 10 weeks Serum concentrations of triglyceride
glucose 10 weeks serum concentration of fasting glucose
Systolic blood pressure 10 weeks Systolic blood pressure (mmHg)
HDL-C 10 weeks Serum concentrations of High-density lipoprotein cholesterol
RANKL 10 weeks Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand
Quality of life index (KDQOL) questionnaire 10 weeks Filling the kidney disease quality of life index (KDQOL) questionnaire
Quality of sleep Pittsburgh Sleep Quality Index (PSQI) questionnaire 10 weeks Filling the Pittsburgh Sleep Quality Index (PSQI) questionnaire
- Secondary Outcome Measures
Name Time Method calcium 10 weeks Serum concentrations of calcium
phosphorous 10 weeks Serum concentrations of phosphorous
iPTH 10 weeks Serum concentrations of Intact parathyroid hormone
albumin 10 weeks Serum concentrations of albumin