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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.
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:
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All subjects will be followed up weekly for 12 weeks and blood samples will be withdrawn at baseline and the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group: | Experimental | 20 patients will receive oral melatonin 5mg tablets 1-hour before bedtime for 12 weeks. |
|
| Placebo | Placebo Comparator | 20 patients will receive one tablet of placebo 1-hour before bedtime for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Dietary Supplement | Puritan's Pride ® Melatonin 5mg tablets orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline Malondialdehyde (MDA) level. | Oxidative stress marker | At baseline and at 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline nuclear factor kappa B (NF-KB) level. | Inflammatory marker | At baseline and at 12 weeks. |
| Change in sleep quality by using Pittsburgh Sleep Quality Index (PSQI) questionnaire |
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All patients will be assessed for eligibility according to the following inclusion and exclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ghadeer Amged, BSc | Contact | +201002217996 | ghadeer.amgad@pharma.asu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Recruiting | Cairo | Abbasseya | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41565787 | Derived | Sayed GA, El Borolossy RM, Said RM, Shaheen SM. Evaluating the antioxidant and anti-inflammatory effect of melatonin in pediatric hemodialysis patients: a randomized, placebo-controlled trial. Sci Rep. 2026 Jan 21;16(1):5024. doi: 10.1038/s41598-025-34264-0. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Prospective, randomized, double-blinded, placebo-controlled trial.
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| Placebo | Other | Placebo tablet once daily. |
|
Sleep quality assessment using the validated Arabic version of PSQI questionnaire.
| At baseline and at 12 weeks. |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |