Effect of Melatonin in Pediatric Hemodialysis Patients

Ain Shams University

Status and phase: Enrolling; Phase 3

Conditions: Hemodialysis Complication; Inflammation; Oxidative Stress

Treatments: Other: Placebo; Dietary Supplement: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT05570526

RHDIRB2020110301 REC#99

Details and patient eligibility

About

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.

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 Blood samples will be withdrawn from each patient before the dialysis session for assay of each of the following: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• All subjects will be followed up weekly for 12 weeks and blood samples will be withdrawn at baseline and the end of the study.

Enrollment: 40 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Intervention group:

Experimental group

Description:

20 patients will receive oral melatonin 5mg tablets 1-hour before bedtime for 12 weeks.

Treatment:

Dietary Supplement: Melatonin

Placebo

Placebo Comparator group

Description:

20 patients will receive one tablet of placebo 1-hour before bedtime for 12 weeks.

Treatment:

Other: Placebo