Hemodialysis Complication, Inflammation, Oxidative Stress
Conditions
Keywords
Pediatric hemodialysis
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.
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 Blood samples will be withdrawn from each patient before the dialysis session for assay of each of the following: 1.Oxidative stress marker malondialdehyde (MDA) by ELISA assay. 2.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 * All subjects will be followed up weekly for 12 weeks and blood samples will be withdrawn at baseline and the end of the study.
Interventions
DIETARY_SUPPLEMENTMelatonin
Puritan's Pride ® Melatonin 5mg tablets orally once daily.
OTHERPlacebo
Placebo tablet once daily.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Prospective, randomized, double-blinded, placebo-controlled trial.
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in baseline Malondialdehyde (MDA) level. | At baseline and at 12 weeks. | Oxidative stress marker |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in baseline nuclear factor kappa B (NF-KB) level. | At baseline and at 12 weeks. | Inflammatory marker |
| 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. |
Countries
Egypt
Contacts
Primary ContactGhadeer Amged, BSc
Outcome results
None listed