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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peritoneal Dialysis
- Sponsor
- National Nutrition and Food Technology Institute
- Enrollment
- 46
- Primary Endpoint
- sICAM-1
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
zahra yari
assistant professor
National Nutrition and Food Technology Institute
Eligibility Criteria
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
Outcomes
Primary Outcomes
sICAM-1
Time Frame: 10 weeks
Serum concentrations of Soluble intercellular adhesion molecule-1
carboxy-methyl lysine
Time Frame: 10 weeks
serum concentration of carboxy-methyl lysine
Osteoprotegerin
Time Frame: 10 weeks
Serum concentrations of Osteoprotegerin
LDL-C
Time Frame: 10 weeks
Serum concentrations of low-density lipoprotein cholesterol
the Beck depression test
Time Frame: 10 weeks
Filling the Beck depression test
Lp (a)
Time Frame: 10 weeks
Serum concentrations of lipoprotein-a
Diastolic blood pressure
Time Frame: 10 weeks
Diastolic blood pressure (mmHg)
Total cholesterol
Time Frame: 10 weeks
Serum concentrations of total cholesterol
MDA
Time Frame: 10 weeks
Serum concentrations of malondialdehyde
hs-CRP
Time Frame: 10 weeks
Serum concentrations of high sensitivity c-reactive protein
pentosidine
Time Frame: 10 weeks
serum concentration of pentosidine
P1NP
Time Frame: 10 weeks
serum concentration of Procollagen 1 Intact N-Terminal Propeptide
TRACP5b
Time Frame: 10 weeks
Serum concentrations of Tartrate-resistant acid phosphatase 5b
triglyceride
Time Frame: 10 weeks
Serum concentrations of triglyceride
glucose
Time Frame: 10 weeks
serum concentration of fasting glucose
Systolic blood pressure
Time Frame: 10 weeks
Systolic blood pressure (mmHg)
HDL-C
Time Frame: 10 weeks
Serum concentrations of High-density lipoprotein cholesterol
RANKL
Time Frame: 10 weeks
Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand
Quality of life index (KDQOL) questionnaire
Time Frame: 10 weeks
Filling the kidney disease quality of life index (KDQOL) questionnaire
Quality of sleep Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time Frame: 10 weeks
Filling the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Secondary Outcomes
- calcium(10 weeks)
- phosphorous(10 weeks)
- iPTH(10 weeks)
- albumin(10 weeks)