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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peritoneal Dialysis
• Intervention / Treatment: Dietary supplement: Melatonin; Other: placebo

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: zahra yari; Phone Number: +982122357484; Email: zahrayari_nut@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Other: placebo; 1 tablet of placebo (starch)
Active Comparator: Melatonin	Dietary supplement: Melatonin; 5 mg Melatonin in one tablet, 30 minutes before night sleep

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Nutrition and Food Technology Institute

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2023
• Primary Completion (Estimated): January 20, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 21, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 21, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: 1402.034

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No