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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06096558
Enrollment
46
Registered
2023-10-23
Start date
2023-10-20
Completion date
2024-05-01
Last updated
2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Dialysis

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.

Interventions

DIETARY_SUPPLEMENTMelatonin

5 mg Melatonin in one tablet, 30 minutes before night sleep

OTHERplacebo

1 tablet of placebo (starch)

Sponsors

National Nutrition and Food Technology Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of sleep Pittsburgh Sleep Quality Index (PSQI) questionnaire10 weeksFilling the Pittsburgh Sleep Quality Index (PSQI) questionnaire
HDL-C10 weeksSerum concentrations of High-density lipoprotein cholesterol
LDL-C10 weeksSerum concentrations of low-density lipoprotein cholesterol
Quality of life index (KDQOL) questionnaire10 weeksFilling the kidney disease quality of life index (KDQOL) questionnaire
the Beck depression test10 weeksFilling the Beck depression test
Lp (a)10 weeksSerum concentrations of lipoprotein-a
MDA10 weeksSerum concentrations of malondialdehyde
hs-CRP10 weeksSerum concentrations of high sensitivity c-reactive protein
sICAM-110 weeksSerum concentrations of Soluble intercellular adhesion molecule-1
glucose10 weeksserum concentration of fasting glucose
pentosidine10 weeksserum concentration of pentosidine
carboxy-methyl lysine10 weeksserum concentration of carboxy-methyl lysine
P1NP10 weeksserum concentration of Procollagen 1 Intact N-Terminal Propeptide
Osteoprotegerin10 weeksSerum concentrations of Osteoprotegerin
TRACP5b10 weeksSerum concentrations of Tartrate-resistant acid phosphatase 5b
RANKL10 weeksSerum concentrations of Receptor activator of nuclear factor kappa-Β ligand
Systolic blood pressure10 weeksSystolic blood pressure (mmHg)
Diastolic blood pressure10 weeksDiastolic blood pressure (mmHg)
triglyceride10 weeksSerum concentrations of triglyceride
Total cholesterol10 weeksSerum concentrations of total cholesterol

Secondary

MeasureTime frameDescription
iPTH10 weeksSerum concentrations of Intact parathyroid hormone
albumin10 weeksSerum concentrations of albumin
calcium10 weeksSerum concentrations of calcium
phosphorous10 weeksSerum concentrations of phosphorous

Contacts

Primary Contactzahra yari
zahrayari_nut@yahoo.com+982122357484

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026