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

Sponsor
National Nutrition and Food Technology Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06096558
Collaborator
(none)
46
Enrollment
2
Arms
6.4
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Melatonin
  • Other: placebo
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Oct 20, 2023
Anticipated Primary Completion Date :
Jan 20, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Melatonin

Dietary Supplement: Melatonin
5 mg Melatonin in one tablet, 30 minutes before night sleep
Placebo Comparator: placebo

Other: placebo
1 tablet of placebo (starch)

Outcome Measures

Primary Outcome Measures

  1. Lp (a) [10 weeks]

    Serum concentrations of lipoprotein-a

  2. MDA [10 weeks]

    Serum concentrations of malondialdehyde

  3. hs-CRP [10 weeks]

    Serum concentrations of high sensitivity c-reactive protein

  4. sICAM-1 [10 weeks]

    Serum concentrations of Soluble intercellular adhesion molecule-1

  5. glucose [10 weeks]

    serum concentration of fasting glucose

  6. pentosidine [10 weeks]

    serum concentration of pentosidine

  7. carboxy-methyl lysine [10 weeks]

    serum concentration of carboxy-methyl lysine

  8. P1NP [10 weeks]

    serum concentration of Procollagen 1 Intact N-Terminal Propeptide

  9. Osteoprotegerin [10 weeks]

    Serum concentrations of Osteoprotegerin

  10. TRACP5b [10 weeks]

    Serum concentrations of Tartrate-resistant acid phosphatase 5b

  11. RANKL [10 weeks]

    Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand

  12. Systolic blood pressure [10 weeks]

    Systolic blood pressure (mmHg)

  13. Diastolic blood pressure [10 weeks]

    Diastolic blood pressure (mmHg)

  14. triglyceride [10 weeks]

    Serum concentrations of triglyceride

  15. Total cholesterol [10 weeks]

    Serum concentrations of total cholesterol

  16. HDL-C [10 weeks]

    Serum concentrations of High-density lipoprotein cholesterol

  17. LDL-C [10 weeks]

    Serum concentrations of low-density lipoprotein cholesterol

  18. Quality of life index (KDQOL) questionnaire [10 weeks]

    Filling the kidney disease quality of life index (KDQOL) questionnaire

  19. the Beck depression test [10 weeks]

    Filling the Beck depression test

  20. Quality of sleep Pittsburgh Sleep Quality Index (PSQI) questionnaire [10 weeks]

    Filling the Pittsburgh Sleep Quality Index (PSQI) questionnaire

Secondary Outcome Measures

  1. albumin [10 weeks]

    Serum concentrations of albumin

  2. calcium [10 weeks]

    Serum concentrations of calcium

  3. phosphorous [10 weeks]

    Serum concentrations of phosphorous

  4. iPTH [10 weeks]

    Serum concentrations of Intact parathyroid hormone

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • National Nutrition and Food Technology Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
zahra yari, assistant professor, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier:
NCT06096558
Other Study ID Numbers:
  • 1402.034
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Melatonin

Study Results

No Results Posted as of Oct 23, 2023