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

National Nutrition and Food Technology Institute

Status: Not yet enrolling

Conditions: Peritoneal Dialysis

Treatments: Dietary Supplement: Melatonin; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06096558

1402.034

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

Melatonin

Active Comparator group

Treatment:

Dietary Supplement: Melatonin

placebo

Placebo Comparator group

Treatment:

Other: placebo