The Effect of Omega-3 Fatty Acids Versus Gabapentin in Uremic Pruritus in Hemodialysis Patients

January 2, 2024 updated by: Ain Shams University

Omega-3 Fatty Acids Versus Gabapentin in Uremic Pruritus in Hemodialysis Patients.

omega-3 fatty acids versus gabapentin in uremic pruritus in hemodialysis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. The score of 6-10 is considered mild pruritus.
  2. The score of 11-20 is considered moderate pruritus.
  3. The score of 21-25 is considered severe pruritus.

So the study group will fulfill the following criteria :

  1. According to 5D itch score a total score of 6-25 points
  2. Meet the international diagnostic criteria for uremic pruritus.
  3. 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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11566
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: prevalent hemodialysis patients >18 years undergoing dialysis who are co operative and not receiving topical or systemic treatment for uremic pruritus for at least 2 week patients who meet the international diagnostic criteria for uremic pruritus

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
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
Drug: Omega 3 fatty acid, gabapentin
To study the effect of omega 3 fatty acids on uremic pruritus in prevalent hemodialysis patients versus the effect of gabapentin
Other Names:
  • Gabapentin
Active Comparator: Group B
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
Drug: Omega 3 fatty acid, gabapentin
To study the effect of omega 3 fatty acids on uremic pruritus in prevalent hemodialysis patients versus the effect of gabapentin
Other Names:
  • Gabapentin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

July 15, 2023

Study Completion (Actual)

July 30, 2023

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 768/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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