Hemodialysis ComplicationPhase 3NCT05570526
Effect of Melatonin in Pediatric Hemodialysis Patients
A Phase 3 study testing Melatonin in people with Hemodialysis Complication and Oxidative Stress, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Hemodialysis Complication, Oxidative Stress, Inflammation
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 25 Mar 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female patients age from 6-18 years old.
- Undergoing regular HD for at least 6 months prior to enrollment
- Not enrolled in any other clinical trial.
- Judged by the physician to be physically stable
Who cannot join
- Patients receiving anti-epileptics.
- Patients with some autoimmune conditions as SLE, RA or post-organ transplant
- Patients taking immunosuppressants.
- Patients taking warfarin.
- Patients receiving vitamin E, green tea or zinc during the past 3 months
- Patients with malignancy and/or active inflammatory disease
- Patients with mal absorption, mental retardation or psychiatric illness.
- Patients who had hemorrhagic episodes or received blood transfusion in the past 3 months prior to the enrollment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospitals
Cairo, Abbasseya
About this study
Official title: Effect Of Melatonin On The Clinical Outcome In Pediatric Hemodialysis Patients
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.
Read the detailed description
- Patients will be recruited and evaluated for eligibility.
- Patients who meet the eligibility criteria will be randomly assigned to either placebo or intervention group.
- 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.
- 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
- Hemodialysis Complication, Oxidative Stress, Inflammation
- Being tested
- Melatonin, Placebo
- Keywords
- Pediatric hemodialysis
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
Puritan's Pride ® Melatonin 5mg tablets orally once daily.
PlaceboOther
Placebo tablet once daily.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: | Experimental | 20 patients will receive oral melatonin 5mg tablets 1-hour before bedtime for 12 weeks. Receives: Dietary Supplement: Melatonin |
| Placebo | Placebo comparator | 20 patients will receive one tablet of placebo 1-hour before bedtime for 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline Malondialdehyde (MDA) level.
Oxidative stress marker
Measured: At baseline and at 12 weeks.
Secondary outcomes (2)
Change in baseline nuclear factor kappa B (NF-KB) level.
Inflammatory marker
Measured: At baseline and at 12 weeks.
Change in sleep quality by using Pittsburgh Sleep Quality Index (PSQI) questionnaire
Sleep quality assessment using the validated Arabic version of PSQI questionnaire.
Measured: At baseline and at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Dec 2022
- Primary completion25 Mar 2023 (estimated)
- Study completion25 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, double-blinded, placebo-controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghadeer Amged, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570526
- Sponsor's protocol ID
- RHDIRB2020110301 REC#99
- Status last verified
- Jan 2023
- First submitted
- 4 Oct 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41565787
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Melatonin On The Clinical Outcome In Pediatric Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05570526
- Acronym / sponsor ID
- RHDIRB2020110301 REC#99
- Conditions
- Hemodialysis Complication, Oxidative Stress, Inflammation
- Keywords
- Pediatric hemodialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 25 Mar 2023 (estimated)
- Study completion
- 25 Mar 2023 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Patients will be recruited and evaluated for eligibility.
- Patients who meet the eligibility criteria will be randomly assigned to either placebo or intervention group.
- 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.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, randomized, double-blinded, placebo-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention group: | Experimental | Dietary Supplement: Melatonin20 patients will receive oral melatonin 5mg tablets 1-hour before bedtime for 12 weeks. |
| Placebo | Placebo comparator | Other: Placebo20 patients will receive one tablet of placebo 1-hour before bedtime for 12 weeks. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male or female patients age from 6-18 years old.
- Undergoing regular HD for at least 6 months prior to enrollment
- Not enrolled in any other clinical trial.
- Judged by the physician to be physically stable
Key exclusion criteria (8 listed)
- Patients receiving anti-epileptics.
- Patients with some autoimmune conditions as SLE, RA or post-organ transplant
- Patients taking immunosuppressants.
- Patients taking warfarin.
- Patients receiving vitamin E, green tea or zinc during the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninPuritan's Pride ® Melatonin 5mg tablets orally once daily. | Dietary supplement | Intervention group: |
| PlaceboPlacebo tablet once daily. | Other | Placebo |
Primary outcome
Change in baseline Malondialdehyde (MDA) level.
Time frame: At baseline and at 12 weeks.
Oxidative stress marker
2 secondary outcomes
Change in baseline nuclear factor kappa B (NF-KB) level.
Time frame: At baseline and at 12 weeks.
Change in sleep quality by using Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time frame: At baseline and at 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Derived from this study: PubMed 41565787Sayed 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Melatonin in people with Hemodialysis Complication and Oxidative Stress, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghadeer Amged, BSc (+201002217996, ghadeer.amgad@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline Malondialdehyde (MDA) level. (time frame: At baseline and at 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05570526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.