Effect of Melatonin in Pediatric Hemodialysis Patients

• Sponsor: Ain Shams University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05570526
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3.7
• Patients Per Site Per Month: 10.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodialysis Complication; Oxidative Stress; Inflammation	Dietary Supplement: Melatonin; Other: Placebo	Phase 3

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 Blood samples will be withdrawn from each patient before the dialysis session for assay of each of the following: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• All subjects will be followed up weekly for 12 weeks and blood samples will be withdrawn at baseline and the end of the study.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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, randomized, double-blinded, placebo-controlled trial.Prospective, randomized, double-blinded, placebo-controlled trial.
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Effect Of Melatonin On The Clinical Outcome In Pediatric Hemodialysis Patients
• Actual Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Mar 25, 2023
• Anticipated Study Completion Date: Mar 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group: 20 patients will receive oral melatonin 5mg tablets 1-hour before bedtime for 12 weeks.	Dietary Supplement: Melatonin; 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.	Other: Placebo; Placebo tablet once daily.

Outcome Measures

Primary Outcome Measures

1. Change in baseline Malondialdehyde (MDA) level. [At baseline and at 12 weeks.]

   Oxidative stress marker

Secondary Outcome Measures

1. Change in baseline nuclear factor kappa B (NF-KB) level. [At baseline and at 12 weeks.]

   Inflammatory marker

2. Change in sleep quality by using Pittsburgh Sleep Quality Index (PSQI) questionnaire [At baseline and at 12 weeks.]

   Sleep quality assessment using the validated Arabic version of PSQI questionnaire.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Hospitals	Cairo	Abbasseya	Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ghadeer Amged, Demonstrator of clinical pharmacy, Ain Shams University
• ClinicalTrials.gov Identifier: NCT05570526
• Other Study ID Numbers: RHDIRB2020110301 REC#99
• First Posted: Oct 6, 2022
• Last Update Posted: Jan 31, 2023
• Last Verified: Jan 1, 2023

• 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
• Keywords provided by Ghadeer Amged, Demonstrator of clinical pharmacy, Ain Shams University: Pediatric hemodialysis
• Additional relevant MeSH terms: Inflammation; Melatonin

Study Results

No Results Posted as of Jan 31, 2023