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
1 other identifier
interventional
46
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2023
CompletedStudy Start
First participant enrolled
October 20, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedOctober 23, 2023
October 1, 2023
3 months
October 10, 2023
October 21, 2023
Conditions
Outcome Measures
Primary Outcomes (20)
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 Outcomes (4)
albumin
10 weeks
calcium
10 weeks
phosphorous
10 weeks
iPTH
10 weeks
Study Arms (2)
Melatonin
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Continuous Ambulatory Peritoneal Dialysis for 6 months or more
- Body mass index (BMI) below 35
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Movahedian M, Tabibi H, Atabak S, Hedayati M, Najafi I, Seyrafian S, Rouhani MH. Effects of melatonin on advanced glycation end products, inflammation, and oxidative stress in peritoneal dialysis patients: a randomized controlled trial. Sci Rep. 2025 Oct 22;15(1):36896. doi: 10.1038/s41598-025-20792-2.
PMID: 41125682DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
October 10, 2023
First Posted
October 23, 2023
Study Start
October 20, 2023
Primary Completion
January 20, 2024
Study Completion
May 1, 2024
Last Updated
October 23, 2023
Record last verified: 2023-10