Effect of Melatonin in Pediatric Hemodialysis Patients

October 5, 2022 updated by: Ghadeer Amged, Ain Shams University

Effect Of Melatonin On The Clinical Outcome In Pediatric Hemodialysis Patients

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.

Study Overview

Detailed Description

  1. Patients will be recruited and evaluated for eligibility.
  2. Patients who meet the eligibility criteria will be randomly assigned to either placebo or intervention group.
  3. Patient demographics, clinical characteristics and full medical and medication history: will be obtained at baseline and every 4 weeks after the beginning of the study.
  4. Blood samples will be withdrawn from each patient before the dialysis session for assay of each of the following:

1.Oxidative stress marker malondialdehyde (MDA) by ELISA assay. 2. Inflammatory marker level nuclear factor kappa B (NF-KB) by ELISA assay 3. Complete blood picture (CBC). 4. Lipid profile (total cholesterol(TC), triglycerides(TG), high-density lipoprotein (HDL) and low-density lipoprotein (LDL) 5)Safety will be assessed weekly after the beginning of the study by monitoring the side effects or any adverse drug reactions.

  • A total of (40) patients on regular HD will be enrolled in the study. These patients will be randomly assigned in a 1:1 ratio into two groups:

    • The first group (n=20):The patients in the first group will receive a total daily dose of 5mg of melatonin tablets 1-hour before bedtime for 12 weeks.
    • The second group (n=20): The patients will receive one tablet of placebo for the same duration.
  • All subjects will sign an informed consent statement prior to inclusion in the study.
  • All subjects will be followed up weekly for 12 weeks and blood samples will be withdrawn at baseline and the end of the study.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Abbasseya
      • Cairo, Abbasseya, Egypt
        • Ain Shams University hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

All patients will be assessed for eligibility according to the following inclusion and exclusion criteria:

Inclusion Criteria:

  1. Male or female patients age from 6-18 years old.
  2. Undergoing regular HD for at least 6 months prior to enrollment
  3. Not enrolled in any other clinical trial.
  4. Judged by the physician to be physically stable

Exclusion Criteria:

  1. Patients receiving anti-epileptics.
  2. Patients with some autoimmune conditions as SLE, RA or post-organ transplant
  3. Patients taking immunosuppressants.
  4. Patients taking warfarin.
  5. Patients receiving vitamin E, green tea or zinc during the past 3 months
  6. Patients with malignancy and/or active inflammatory disease
  7. Patients with mal absorption, mental retardation or psychiatric illness.
  8. Patients who had hemorrhagic episodes or received blood transfusion in the past 3 months prior to the enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group:
20 patients will receive oral melatonin 5mg tablets 1-hour before bedtime for 12 weeks.
Puritan's Pride ® Melatonin 5mg tablets orally once daily.
Placebo Comparator: Placebo
20 patients will receive one tablet of placebo 1-hour before bedtime for 12 weeks.
Placebo tablet once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in baseline Malondialdehyde (MDA) level.
Time Frame: At baseline and at 12 weeks.
Oxidative stress marker
At baseline and at 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in baseline nuclear factor kappa B (NF-KB) level.
Time Frame: At baseline and at 12 weeks.
Inflammatory marker
At baseline and at 12 weeks.
Change in sleep quality by using Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time Frame: At baseline and at 12 weeks.
Sleep quality assessment using the validated Arabic version of PSQI questionnaire.
At baseline and at 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

October 4, 2022

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 5, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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