Effect of Melatonin in Pediatric Hemodialysis Patients
Effect Of Melatonin On The Clinical Outcome In Pediatric Hemodialysis Patients
1 other identifier
interventional
40
1 country
1
Brief Summary
A Prospective, randomized, double-blinded, placebo-controlled trial will be conducted at the pediatric dialysis unit, Children's Hospital, Ain Shams University in order to investigate the benefits of melatonin supplementation on oxidative stress, inflammation and to assess sleep quality by using PSQI questionnaire in pediatric hemodialysis patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2022
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2022
CompletedFirst Posted
Study publicly available on registry
October 6, 2022
CompletedStudy Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2023
CompletedJanuary 31, 2023
January 1, 2023
4 months
October 4, 2022
January 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in baseline Malondialdehyde (MDA) level.
Oxidative stress marker
At baseline and at 12 weeks.
Secondary Outcomes (2)
Change in baseline nuclear factor kappa B (NF-KB) level.
At baseline and at 12 weeks.
Change in sleep quality by using Pittsburgh Sleep Quality Index (PSQI) questionnaire
At baseline and at 12 weeks.
Study Arms (2)
Intervention group:
EXPERIMENTAL20 patients will receive oral melatonin 5mg tablets 1-hour before bedtime for 12 weeks.
Placebo
PLACEBO COMPARATOR20 patients will receive one tablet of placebo 1-hour before bedtime for 12 weeks.
Interventions
Eligibility Criteria
You may not qualify if:
- Male or female patients age from 6-18 years old.
- Undergoing regular HD for at least 6 months prior to enrollment
- Not enrolled in any other clinical trial.
- Judged by the physician to be physically stable
- Patients receiving anti-epileptics.
- Patients with some autoimmune conditions as SLE, RA or post-organ transplant
- Patients taking immunosuppressants.
- Patients taking warfarin.
- Patients receiving vitamin E, green tea or zinc during the past 3 months
- Patients with malignancy and/or active inflammatory disease
- Patients with mal absorption, mental retardation or psychiatric illness.
- Patients who had hemorrhagic episodes or received blood transfusion in the past 3 months prior to the enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University Hospitals
Cairo, Abbasseya, Egypt
Related Publications (1)
Sayed GA, El Borolossy RM, Said RM, Shaheen SM. Evaluating the antioxidant and anti-inflammatory effect of melatonin in pediatric hemodialysis patients: a randomized, placebo-controlled trial. Sci Rep. 2026 Jan 21. doi: 10.1038/s41598-025-34264-0. Online ahead of print.
PMID: 41565787DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Demonstrator of clinical pharmacy
Study Record Dates
First Submitted
October 4, 2022
First Posted
October 6, 2022
Study Start
December 1, 2022
Primary Completion
March 25, 2023
Study Completion
March 25, 2023
Last Updated
January 31, 2023
Record last verified: 2023-01