Uremic Pruritus in Hemodialysis PatientsNCT06190132
The Effect of Omega-3 Fatty Acids Versus Gabapentin in Uremic Pruritus in Hemodialysis Patients
A study testing Omega 3 fatty acid, gabapentin in people with Uremic Pruritus in Hemodialysis Patients, run by Ain Shams University at 1 site in Egypt.
Trial summary
omega-3 fatty acids versus gabapentin in uremic pruritus in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Uremic Pruritus in Hemodialysis Patients
- What is being tested?
- Omega 3 fatty acid, gabapentin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 30 Jul 2023
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with primary dermatological disease causing itching as atopic dermatitis, psoriasis, scabies, drug reaction Patients with any systemic disease that can cause pruritus as hepatic cholestasis , active infections (hepatitis B, and hepatitis c PCR positive, HIV) Patients under steroid treatment. current treatment of uremic pruritus. Concomitant malignancy (Hodgkins lymphoma, leukemia, multiple myeloma) Kidney transplantation (immunosuppressive medications Contraindications to omega 3 as patients using anticoagulants, or patients who have bleeding tendency, chronic diarrhea, history of malabsorption or allergic reaction to omega 3 Contraindications to gabapentin as in patients who have depression , suicidal thoughts, myasthenia Gravis, skeletal muscles disorder, patients who have history of allergic reactions to gabapentin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Omega-3 Fatty Acids Versus Gabapentin in Uremic Pruritus in Hemodialysis Patients.
omega-3 fatty acids versus gabapentin in uremic pruritus in hemodialysis patients.
Read the detailed description
Patients who were enrolled in the study used no antipruritic therapy for at least 2 weeks before the study. The patients were randomly assigned to Group A, or Group B. Patients in Group A (25participants) were allocated to treatment with omega-3 daily (2capsules of 1gm omega-3 a day) (Shayanpour et al.,2019). Patients in Group B (25 participants) received gabapentin (one capsule of gaptin 100mg thrice weekly post HD session) (KDIGO Clinical practice guidelines,2019) Patients in the 2 groups received treatment for four weeks then after washout period(6 weeks), the treatment was changed between the 2 groups. pruritus severity was assessed by 5D-Itch score before the study and at the end of each treatment period. Throughout the study, the level of PGE2 and the pruritus severity was measured at the baseline before treatment, after 4 weeks and after 14 weeks (post treatment) by 5-D itch scale.
5-D itch scale was made to be used for outcome measurement in clinical trials. It depends on five main domains for measurement of pruritus severity which are (duration, degree, direction, disability and distribution) (Elman et al.,2010). The score of each domain is made separately then the scores of all domains summed together to obtain the total 5-D score pruritus). Patients with score 5 or less considered having no itching and patients with scores from 6 to 25 considered itch patients.
The total 5-D score can be classified into:
- The score of 6-10 is considered mild pruritus.
- The score of 11-20 is considered moderate pruritus.
- The score of 21-25 is considered severe pruritus.
So the study group will fulfill the following criteria :
- According to 5D itch score a total score of 6-25 points
- Meet the international diagnostic criteria for uremic pruritus.
- Meet the exclusion criteria of the study. The total score can range from 5(which mean no pruritus) to 25 (which mean most severe
- Conditions
- Uremic Pruritus in Hemodialysis Patients
- Being tested
- Omega 3 fatty acid, gabapentin
- Keywords
- Hemodialysis patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 fatty acid, gabapentinDrug
Also called Gabapentin
To study the effect of omega 3 fatty acids on uremic pruritus in prevalent hemodialysis patients versus the effect of gabapentin
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A allocated to treatment with omega 3 fatty acids for 4 weeks then after 6 weeks washout period, the patients received gabapentin for 4 weeks Receives: Drug: Omega 3 fatty acid, gabapentin |
| Group B | Active comparator | Group B allocated to treatment with gabapentin for 4 weeks then after 6 weeks washout period, the patients received omega 3 fatty acids for 4 weeks Receives: Drug: Omega 3 fatty acid, gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 Dimensions itch scale, prostaglandin E2
5 Dimensions itch scale used for measurement of pruritus severity and outcome measurement in clinical trials score from 6 to 25 considered to have pruritus, PGE2 used for assessment of pruritus as its produced in cases of inflammation, involved in pain sensation
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Apr 2023
- Primary completion15 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uremic Pruritus in Hemodialysis PatientsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190132
- Sponsor's protocol ID
- 768/2022
- Status last verified
- Oct 2023
- First submitted
- 28 Nov 2023
- Last updated
- 5 Jan 2024
- 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids Versus Gabapentin in Uremic Pruritus in Hemodialysis Patients.
- ClinicalTrials.gov ID
- NCT06190132
- Acronym / sponsor ID
- 768/2022
- Conditions
- Uremic Pruritus in Hemodialysis Patients
- Keywords
- Hemodialysis patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 5 Jan 2024 (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.
omega-3 fatty acids versus gabapentin in uremic pruritus in hemodialysis patients.
Detailed description
Patients who were enrolled in the study used no antipruritic therapy for at least 2 weeks before the study. The patients were randomly assigned to Group A, or Group B. Patients in Group A (25participants) were allocated to treatment with omega-3 daily (2capsules of 1gm omega-3 a day) (Shayanpour et al.,2019). Patients in Group B (25 participants) received gabapentin (one capsule of gaptin 100mg thrice weekly post HD session) (KDIGO Clinical practice guidelines,2019) Patients in the 2 groups received treatment for four weeks then after washout period(6 weeks), the treatment was changed between the 2 groups. pruritus severity was assessed by 5D-Itch score before the study and at the end of each treatment period. Throughout the study, the level of PGE2 and the pruritus severity was measured at the baseline before treatment, after 4 weeks and after 14 weeks (post treatment) by 5-D itch scale.
5-D itch scale was made to be used for outcome measurement in clinical trials. It depends on five main domains for measurement of pruritus severity which are (duration, degree, direction, disability and distribution) (Elman et al.,2010). The score of each domain is made separately then the scores of all domains summed together to obtain the total 5-D score pruritus). Patients with score 5 or less considered having no itching and patients with scores from 6 to 25 considered itch patients.
The total 5-D score can be classified into:
- The score of 6-10 is considered mild pruritus.
- The score of 11-20 is considered moderate pruritus.
- The score of 21-25 is considered severe pruritus.
So the study group will fulfill the following criteria :
- According to 5D itch score a total score of 6-25 points
- Meet the international diagnostic criteria for uremic pruritus.
- Meet the exclusion criteria of the study. The total score can range from 5(which mean no pruritus) to 25 (which mean most severe
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Omega 3 fatty acid, gabapentinGroup A allocated to treatment with omega 3 fatty acids for 4 weeks then after 6 weeks washout period, the patients received gabapentin for 4 weeks |
| Group B | Active comparator | Drug: Omega 3 fatty acid, gabapentinGroup B allocated to treatment with gabapentin for 4 weeks then after 6 weeks washout period, the patients received omega 3 fatty acids for 4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients with primary dermatological disease causing itching as atopic dermatitis, psoriasis, scabies, drug reaction Patients with any systemic disease that can cause pruritus as hepatic cholestasis , active infections (hepatitis B, and hepatitis c PCR positive, HIV) Patients under steroid treatment. current treatment of uremic pruritus. Concomitant malignancy (Hodgkins lymphoma, leukemia, multiple myeloma) Kidney transplantation (immunosuppressive medications Contraindications to omega 3 as patients using anticoagulants, or patients who have bleeding tendency, chronic diarrhea, history of malabsorption or allergic reaction to omega 3 Contraindications to gabapentin as in patients who have depression , suicidal thoughts, myasthenia Gravis, skeletal muscles disorder, patients who have history of allergic reactions to gabapentin
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 3 fatty acid, gabapentinAlso: GabapentinTo study the effect of omega 3 fatty acids on uremic pruritus in prevalent hemodialysis patients versus the effect of gabapentin | Drug | Group A, Group B |
Primary outcome
5 Dimensions itch scale, prostaglandin E2
Time frame: 14 weeks
5 Dimensions itch scale used for measurement of pruritus severity and outcome measurement in clinical trials score from 6 to 25 considered to have pruritus, PGE2 used for assessment of pruritus as its produced in cases of inflammation, involved in pain sensation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3 fatty acid, gabapentin in people with Uremic Pruritus in Hemodialysis Patients, 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 0 inclusion and 1 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: finished, as of the sponsor's last update on 5 Jan 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
5 Dimensions itch scale, prostaglandin E2 (time frame: 14 weeks). 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 5 Jan 2024.