Pediatric Patients Having Renal Failure and on Regular HemodialysisPhase 3NCT05627843
Effects of Curcumin on Inflammation and Oxidative Stress in Pediatric Patients on Regular Hemodialysis: A Randomized, Double-Blind, Placebo-Controlled Pilot Study
A Phase 3 study testing Curcumin capsules 1 gm in people with Pediatric Patients Having Renal Failure and on Regular Hemodialysis, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study will be a randomised, double blinded, placebo controlled design. It will include 2 groups : trial group and placebo group Patients in both groups are children on regular hemodialysis The patients in the trial group will receive Curcumin capsule 1 gm for 3 months , and the placebo group will receive a placebo… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Pediatric Patients Having Renal Failure and on Regular Hemodialysis
- What is being tested?
- Curcumin capsules 1 gm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 1 Feb 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female pediatric patients with weight of at least 30 kilograms.
- Undergoing regular hemodialysis for at least 6 months.
Who cannot join
- Bleeding disorders.
- Chronic liver disease.
- Diabetes mellitus.
- Autoimmune diseases.
- Receiving drugs that are contraindicated, or have major interactions with curcumin, and can't be discontinued or replaced.
- Receiving corticosteroids, or immune-suppressants.
- Patients taking any antioxidant supplements including vitamin E, ascorbic acid, omega -3 fatty acid, or L-carnitine within 3 months prior to enrollment in our study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Iman Mohamed Naguib Alagamy
Cairo
Iman Alagamy
About this study
Official title: Effects of Curcumin on Inflammation and Oxidative Stress in Paediatric Patients on Regular Hemodialysis: A Randomized, Double-Blind, Placebo-Controlled Pilot Study
- The study will be a randomised, double blinded, placebo controlled design.
- It will include 2 groups : trial group and placebo group
- Patients in both groups are children on regular hemodialysis
- The patients in the trial group will receive Curcumin capsule 1 gm for 3 months , and the placebo group will receive a placebo capsule for 3 months
- All patients will be evaluated clinically, and laboratory at baseline, at 3 months after end of supplementation.
- Being tested
- Curcumin capsules 1 gm, Placebo capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin capsules 1 gmDietary supplement
Dietary supplement
Placebo capsuleDietary supplement
placebo corn starch
| Study group | Role | What they receive |
|---|---|---|
| Trial group | Experimental | Children on regular hemodialysis whose weight 30 kg or above Receives: Dietary Supplement: Curcumin capsules 1 gm |
| Placebo group | Placebo comparator | Children on regular hemodialysis whose weight 30 kg or above Receives: Dietary Supplement: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammatory marker
high sensitivity C reactive protein (CRP) at baseline before supplementation and after 3 months of supplementation
Measured: 3 months
Secondary outcomes (1)
Oxidative stress markers
Serum tumor necrotizing factor alpha (TNF alpha)and malondialdehyde (MDA)at baseline and after 3 months of supplementation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start1 Dec 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Patients Having Renal Failure and on Regular HemodialysisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iman Mohamed Naguib Alagamy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627843
- Sponsor's protocol ID
- MD 181 / 2021
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Curcumin on Inflammation and Oxidative Stress in Paediatric Patients on Regular Hemodialysis: A Randomized, Double-Blind, Placebo-Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05627843
- Acronym / sponsor ID
- MD 181 / 2021
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 28 Nov 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.
- The study will be a randomised, double blinded, placebo controlled design.
- It will include 2 groups : trial group and placebo group
- Patients in both groups are children on regular hemodialysis
- The patients in the trial group will receive Curcumin capsule 1 gm for 3 months , and the placebo group will receive a placebo capsule for 3 months
- All patients will be evaluated clinically, and laboratory at baseline, at 3 months after end of supplementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial group | Experimental | Dietary Supplement: Curcumin capsules 1 gmChildren on regular hemodialysis whose weight 30 kg or above |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo capsuleChildren on regular hemodialysis whose weight 30 kg or above |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Male or female pediatric patients with weight of at least 30 kilograms.
- Undergoing regular hemodialysis for at least 6 months.
Key exclusion criteria (7 listed)
- Bleeding disorders.
- Chronic liver disease.
- Diabetes mellitus.
- Autoimmune diseases.
- Receiving drugs that are contraindicated, or have major interactions with curcumin, and can't be discontinued or replaced.
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 |
|---|---|---|
| Curcumin capsules 1 gmDietary supplement | Dietary supplement | Trial group |
| Placebo capsuleplacebo corn starch | Dietary supplement | Placebo group |
Primary outcome
inflammatory marker
Time frame: 3 months
high sensitivity C reactive protein (CRP) at baseline before supplementation and after 3 months of supplementation
1 secondary outcome
Oxidative stress markers
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
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 Curcumin capsules 1 gm in people with Pediatric Patients Having Renal Failure and on Regular Hemodialysis, 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 2 inclusion and 7 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 28 Nov 2022. 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 Iman Alagamy, Master degree in pediatrics (01201724974, Iman.agamy@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammatory marker (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2022.