Trials / Unknown
UnknownNCT06096558
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- Sponsor
- National Nutrition and Food Technology Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Melatonin | 5 mg Melatonin in one tablet, 30 minutes before night sleep |
| OTHER | placebo | 1 tablet of placebo (starch) |
Timeline
- Start date
- 2023-10-20
- Primary completion
- 2024-01-20
- Completion
- 2024-05-01
- First posted
- 2023-10-23
- Last updated
- 2023-10-23
Source: ClinicalTrials.gov record NCT06096558. Inclusion in this directory is not an endorsement.