Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
40 participants
INTERVENTIONAL
2022-12-01
2023-03-25
Brief Summary
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Detailed Description
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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 Blood samples will be withdrawn from each patient before the dialysis session for assay of each of the following: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* All subjects will be followed up weekly for 12 weeks and blood samples will be withdrawn at baseline and the end of the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Intervention group:
20 patients will receive oral melatonin 5mg tablets 1-hour before bedtime for 12 weeks.
Melatonin
Puritan's Pride ® Melatonin 5mg tablets orally once daily.
Placebo
20 patients will receive one tablet of placebo 1-hour before bedtime for 12 weeks.
Placebo
Placebo tablet once daily.
Interventions
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Melatonin
Puritan's Pride ® Melatonin 5mg tablets orally once daily.
Placebo
Placebo tablet once daily.
Eligibility Criteria
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Inclusion Criteria
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
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.
6 Years
18 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Ghadeer Amged
Demonstrator of clinical pharmacy
Locations
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Ain Shams University Hospitals
Cairo, Abbasseya, Egypt
Countries
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Central Contacts
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Other Identifiers
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RHDIRB2020110301 REC#99
Identifier Type: -
Identifier Source: org_study_id
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