End Stage Renal DiseasePhase 2NCT02581449
Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis
A Phase 2 study testing omega-3 and empty soft gelatin capsules in people with End Stage Renal Disease, run by Ain Shams University.
Trial summary
The purpose of the study is to evaluate the effect of omega-3 fatty acids supplementation on pediatric patients undergoing hemodialysis via the measurement of the following before and after omega-3 administration:oxidative stress markers, inflammatory markers and serum lipids. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- omega-3 and empty soft gelatin capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jan 2016
- Phase
- Phase 2
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients between 8 and 18 years old
- Patients treated with HD for at least 6 months
Who cannot join
- Patients with malignancy and active inflammatory disease.
- Patients who received vitamin E or any antioxidant treatment during the past 3 months.
About this study
Official title: Evaluation of the Effect of Omega-3 Fatty Acids Supplementation on Pediatric Patients Undergoing Hemodialysis
The purpose of the study is to evaluate the effect of omega-3 fatty acids supplementation on pediatric patients undergoing hemodialysis via the measurement of the following before and after omega-3 administration:oxidative stress markers, inflammatory markers and serum lipids.
- Conditions
- End Stage Renal Disease
- Being tested
- omega-3, empty soft gelatin capsules
- Keywords
- omega-3 fatty acids, hemodialysis, oxidative stress, dyslipidemia
- Medical subject headings
- Kidney Failure, Chronic, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3Dietary supplement
Also called NOW foods omega-3 softgels
dietary supplement
empty soft gelatin capsulesOther
empty softgels of matched size, shape and color
| Study group | Role | What they receive |
|---|---|---|
| omega-3 group | Experimental | omega-3 soft gelatin capsules 1000 mg (500mg EPA+250mg DHA)once daily for four months Receives: Dietary Supplement: omega-3 |
| placebo group | Placebo comparator | empty soft gelatin capsules with matched size, color and shape once daily for four months Receives: Other: empty soft gelatin capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect on oxidative stress status via measurement of superoxide dismutase and glutathione peroxidase and malondialdehyde
Measured: four months
Secondary outcomes (1)
effect on serum lipid levels (HDL cholesterol, LDL cholesterol, total cholesterol, and triglycerides)
Measured: four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Areej Mohamed Ateya, Ain Shams University
- Investigators
- Ain Shams, Principal investigator, university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581449
- Sponsor's protocol ID
- PHCL31528
- Status last verified
- Oct 2015
- First submitted
- 11 Oct 2015
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Omega-3 Fatty Acids Supplementation on Pediatric Patients Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT02581449
- Acronym / sponsor ID
- PHCL31528
- Conditions
- End Stage Renal Disease
- Keywords
- omega-3 fatty acids, hemodialysis, oxidative stress, dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 21 Oct 2015 (estimated)
- 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 purpose of the study is to evaluate the effect of omega-3 fatty acids supplementation on pediatric patients undergoing hemodialysis via the measurement of the following before and after omega-3 administration:oxidative stress markers, inflammatory markers and serum lipids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omega-3 group | Experimental | Dietary Supplement: omega-3omega-3 soft gelatin capsules 1000 mg (500mg EPA+250mg DHA)once daily for four months |
| placebo group | Placebo comparator | Other: empty soft gelatin capsulesempty soft gelatin capsules with matched size, color and shape once daily for four months |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients between 8 and 18 years old
- Patients treated with HD for at least 6 months
Key exclusion criteria (2 listed)
- Patients with malignancy and active inflammatory disease.
- Patients who received vitamin E or any antioxidant treatment 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 |
|---|---|---|
| omega-3Also: NOW foods omega-3 softgelsdietary supplement | Dietary supplement | omega-3 group |
| empty soft gelatin capsulesempty softgels of matched size, shape and color | Other | placebo group |
Primary outcome
effect on oxidative stress status via measurement of superoxide dismutase and glutathione peroxidase and malondialdehyde
Time frame: four months
1 secondary outcome
effect on serum lipid levels (HDL cholesterol, LDL cholesterol, total cholesterol, and triglycerides)
Time frame: four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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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.
Ain Shams principal investigator
university
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing omega-3 and empty soft gelatin capsules in people with End Stage Renal Disease, run by Ain Shams University.
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 2 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 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect on oxidative stress status via measurement of superoxide dismutase and glutathione peroxidase and malondialdehyde (time frame: four 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 21 Oct 2015.