Determination of effect of omega-3 supplement on uremic pruritus in hemodialysis patients
Design
Randomised clinical trial with control group and blinded outcome , that assessor and patient and statistician were blinded on 64 hemodialysis patients with uremic pruritus(32 patients in intervention group with omega-3 and 32 patients in placebo group), that were selected by Allocation Concealment.
Settings and conduct
This study was done in hemodialysis ward of Emam Khomeini and Razi hospital of Ahwaz. Patients were divided into control and intervention groups randomly by using blocks of six for allocation concealment.To reduce the risk of bias, patients and assessor and statistician were blinded to know the type of treatment assigned to each person and that which patient was in which group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: hemodialysis patients with uremic pruritus who were more than 18 years old
Exclusion criteria: patients who were suffered from skin diseases or liver diseases or malignancy or allergy to omega-3. If there were any change in their treatment (such as kidney transplantation) they were excluded from the study.
Intervention groups
Hemodialysis patients with uremic pruritus were over 18 years old and their hemodialysis were more than three months and didn't have liver diseases, skin diseases, malignancy and allergy to Omega-3 supplements were divided into control and intervention groups randomly by using blocks of six for allocation concealment. Patients in the intervention group were received 2gr Omega-3 orally , single dose daily before lunch for three weeks. Patients in the control group were received placebo orally, single dose daily before lunch as well.Placebo capsules were similar to Omega-3 capsules in color, shape, size and taste.
Main outcome variables
Pruritus severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171220037968N1
Registration date:2018-04-27, 1397/02/07
Registration timing:retrospective
Last update:2018-04-27, 1397/02/07
Update count:0
Registration date
2018-04-27, 1397/02/07
Registrant information
Name
Parastoo Lakhaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 2802
Email address
lakhaei.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-30, 1396/07/08
Expected recruitment end date
2018-01-15, 1396/10/25
Actual recruitment start date
2017-11-29, 1396/09/08
Actual recruitment end date
2018-02-14, 1396/11/25
Trial completion date
empty
Scientific title
Effect of omega-3 supplement on uremic pruritus in hemodialysis patients
Public title
Effect of omega-3 on uremic pruritus hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All of hemodialysis patients with uremic pruritus that their hemodialysis were started at least since three months ago
Exclusion criteria:
Patients with skin disease
Patients with liver disease
Patients with malignancy
Patients who were allergic to omega-3
Age
From 19 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Actual sample size reached:
64
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning of the study, patients equally were divided into two groups (intervention with omega-3 group and placebo group) that used anti pruritis agents approximately the same. Sampling of patients who entered the study with a Non-probabilistic sampling
method was done sequentially. It means that from the beginning of study, all patients who had Inclusion criteria and didn't have exclusion criteria, were selected as sample and this was continued to reach the final sample size. Allocation of patients into each groups(intervention and placebo)was done by the Randomized Block Design (each block consist of six patients).
Finally, patients were divided into two main groups (intervention and control group). To increase assurance and preventing of bias Allocation Concealment were used and unique code were given to each person.
Blinding (investigator's opinion)
Double blinded
Blinding description
To reduce the risk of bias, patients and assessor and statistician were blinded to know the type of treatment assigned to each person and that which patient was in which group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of َAhvaz Jundishapur University of Medical Sciences
Street address
Golestan St., Jundishapur University of Medical Sciences, Vice Chancellor for Research and Technolog
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2017-07-29, 1396/05/07
Ethics committee reference number
IR.AJUMS.REC.1396.631
Health conditions studied
1
Description of health condition studied
Hemodialysis patients
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
Degree of pruritus in hemodialysis patients
Timepoint
Before and 3 weeks after studing
Method of measurement
5D ITCH SCALE Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Omega-3 capsule (1gr) that its trade name was OmegaREX made by Daana Pharma Co. was used 2gr single dose before lunch along three weeks
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule (1gr)that made by Faculty of Pharmacy, Ahvaz Jundishapur University of Medical Sciences with lactose and Avesil was used 2gr single dose before lunch along three weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis ward of ٍEmam khomeini Hospital of Ahvaz
Full name of responsible person
Dr. Shokouh Shayanpour- Assistant professor
Street address
Azadegan St.
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Email
Dr.shayanpour@yahoo.com
2
Recruitment center
Name of recruitment center
Hemodialysis ward of Razi Hospital of Ahvaz
Full name of responsible person
Dr. Shokouh Shayanpour- Assistant professor
Street address
Felestin St.
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 1333 5935
Email
Dr.shayanpour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
ِDr. Hatam Boustani
Street address
Golestan St.
City
Ahavaz
Province
Khouzestan
Postal code
39345-61355
Phone
+98 61 3333 7077
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Shokouh Shayanpour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Azadegan St.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3292 1839
Email
Dr.shayanpour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Shokouh Shayanpour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrologist
Street address
َAzadegan St.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3311
Email
shayanpour.sh@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Shokouh Shayanpour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrologist
Street address
َAzadegan St.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3222 2922
Email
shayanpour.sh@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available