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NCT06096558
The Effects of Melatonin on Cardiovascular and Bone Metabolism Markers in Peritoneal Dialysis Patients
NA trial testing Melatonin in Peritoneal Dialysis in 46 participants. Status unknown.
20 January 2024
Quick facts
| Lead sponsor | National Nutrition and Food Technology Institute |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 20 October 2023 |
| Primary completion | 20 January 2024 |
| Estimated completion | 1 May 2024 |
Drugs / interventions tested
- Melatonin (MELATONIN) — full drug profile →
- placebo
Conditions studied
- Peritoneal Dialysis — all drugs for Peritoneal Dialysis →
Sponsor
National Nutrition and Food Technology Institute
Who can join
Adults 18 to 75, any sex, with Peritoneal Dialysis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effects of melatonin on advanced glycation end products, inflammation, and oxidative stress in peritoneal dialysis patients: a randomized controlled trial.
Movahedian M, Tabibi H, Atabak S, Hedayati M, et al · · 2025 · PMID 41125682 · DOI 10.1038/s41598-025-20792-2
Verify or expand the search:
- PubMed search for NCT06096558
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Melatonin
Trials testing the same drug.
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- NCT07503600 — The Effect of Adjunctive Melatonin With Colistin in Patients With Multidrug-Resistant Gram-Negative Bacterial Infections · Phase 3 · not yet recruiting
- NCT07375342 — Melatonin for Post Tonsillectomy Emergence Agitation in Pediatric · NA · enrolling by invitation
- NCT07305350 — EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES · Phase 2 · active not recruiting
- NCT07096635 — Oral Melatonin With Intra Articular Analgesia on Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction · NA · not yet recruiting
Other recruiting trials for Peritoneal Dialysis
Currently open trials in the same condition.
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- NCT07077538 — Clinical Study of the Use of Amino Acid Peritoneal Dialysate in Diabetic Patients · NA · recruiting
- NCT06876987 — The Mobile-based Training System in Peritoneal Dialysis Patients · NA · recruiting
- NCT06641765 — Continuous Glucose Monitoring in Dialysis Patients With Diabetes · NA · active not recruiting
- NCT06368713 — Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients · NA · recruiting
Other National Nutrition and Food Technology Institute trials
Trials by the same sponsor.
- NCT06900946 — Evaluation of the Effects of Gluten Free Diet on Clinical Symptoms and Glycemic Index in Type 2 Diabetic Patients With N · NA · enrolling by invitation
- NCT06351696 — The Effects of Bromelain Supplement in Patients With Ulcerative Colitis · NA · recruiting
- NCT06353633 — The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease · NA · not yet recruiting
- NCT06160830 — The Effects of Synbiotic on Cardiovascular and Bone Metabolism Markers in Transplanted Kidney Patients · NA · unknown
- NCT05975866 — The Effects of an Anti-inflammatory Diet With or Without Curcumin Supplementation on Anthropometric Measurements, Concen · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06096558 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Nutrition and Food Technology Institute
- Last refreshed: 23 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06096558.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing