- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05570526
Effect of Melatonin in Pediatric Hemodialysis Patients
Effect Of Melatonin On The Clinical Outcome In Pediatric Hemodialysis Patients
Study Overview
Status
Intervention / Treatment
Detailed Description
- Patients will be recruited and evaluated for eligibility.
- Patients who meet the eligibility criteria will be randomly assigned to either placebo or intervention group.
- 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.
- Blood samples will be withdrawn from each patient before the dialysis session for assay of each of the following: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- All subjects will be followed up weekly for 12 weeks and blood samples will be withdrawn at baseline and the end of the study.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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Ghadeer Amged, BSc
- Phone Number: +201002217996
- Email: ghadeer.amgad@pharma.asu.edu.eg
Study Locations
-
-
Abbasseya
-
Cairo, Abbasseya, Egypt
- Ain Shams University hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
All patients will be assessed for eligibility according to the following inclusion and exclusion criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
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
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHDIRB2020110301 REC#99
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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