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

Peritoneal Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06096558
• Other study ID #: 1402.034
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: October 2023
• Source: National Nutrition and Food Technology Institute
• Contact: zahra yari
• Phone: +982122357484
• Email: zahrayari_nut[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: May 1, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Peritoneal Dialysis

Intervention

Dietary Supplement:
• Melatonin
5 mg Melatonin in one tablet, 30 minutes before night sleep

Other:
• placebo
1 tablet of placebo (starch)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lp (a)	Serum concentrations of lipoprotein-a	10 weeks
Primary	MDA	Serum concentrations of malondialdehyde	10 weeks
Primary	hs-CRP	Serum concentrations of high sensitivity c-reactive protein	10 weeks
Primary	sICAM-1	Serum concentrations of Soluble intercellular adhesion molecule-1	10 weeks
Primary	glucose	serum concentration of fasting glucose	10 weeks
Primary	pentosidine	serum concentration of pentosidine	10 weeks
Primary	carboxy-methyl lysine	serum concentration of carboxy-methyl lysine	10 weeks
Primary	P1NP	serum concentration of Procollagen 1 Intact N-Terminal Propeptide	10 weeks
Primary	Osteoprotegerin	Serum concentrations of Osteoprotegerin	10 weeks
Primary	TRACP5b	Serum concentrations of Tartrate-resistant acid phosphatase 5b	10 weeks
Primary	RANKL	Serum concentrations of Receptor activator of nuclear factor kappa-? ligand	10 weeks
Primary	Systolic blood pressure	Systolic blood pressure (mmHg)	10 weeks
Primary	Diastolic blood pressure	Diastolic blood pressure (mmHg)	10 weeks
Primary	triglyceride	Serum concentrations of triglyceride	10 weeks
Primary	Total cholesterol	Serum concentrations of total cholesterol	10 weeks
Primary	HDL-C	Serum concentrations of High-density lipoprotein cholesterol	10 weeks
Primary	LDL-C	Serum concentrations of low-density lipoprotein cholesterol	10 weeks
Primary	Quality of life index (KDQOL) questionnaire	Filling the kidney disease quality of life index (KDQOL) questionnaire	10 weeks
Primary	the Beck depression test	Filling the Beck depression test	10 weeks
Primary	Quality of sleep Pittsburgh Sleep Quality Index (PSQI) questionnaire	Filling the Pittsburgh Sleep Quality Index (PSQI) questionnaire	10 weeks
Secondary	albumin	Serum concentrations of albumin	10 weeks
Secondary	calcium	Serum concentrations of calcium	10 weeks
Secondary	phosphorous	Serum concentrations of phosphorous	10 weeks
Secondary	iPTH	Serum concentrations of Intact parathyroid hormone	10 weeks