Pruritus is a common complaint in patients under maintenance dialysis. One of the proposed etiologies for pruritus in these patients is the inflammatory mediator derived from abnormal metabolic of fatty acids in ESRD patient. Considering the fact that EPA (eicosa pentatonic acid) which is direct metabolite of omega3 has anti-inflammatory and anti-pruritus activity and although its low concentration in plasma of ESRD patient, we conducted this study to evaluate the efficacy of omega3 in the management of pruritus in patients under peritoneal dialysis. This is a double-blind, placebo-controlled, randomized trial which lasted 14 weeks. In this study, patients with ESRD that were on peritoneal dialysis at least for a months and were not receiving any other anti-itching drugs and weren’t sensitive to omega3 were included. Patients waiting for transplantation, having hyperparathyroidism or increased phosphatase or PT or INR are excluded. 20 subjects in the intervention group received 3 capsules of omega3 (1000 mg) and 20 subjects in the control group received placebo. Itching was measured before and every 2 week after beginning of intervention by VAS method and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138808202370N5
Registration date:2012-01-22, 1390/11/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-22, 1390/11/02
Registrant information
Name
Mojgan Mortazavi
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1260 2593
Email address
m_mortazavi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2009-08-20, 1388/05/29
Expected recruitment end date
2010-02-18, 1388/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of omega3 on pruritus score in patients under peritoneal dialysis
Public title
Evaluation of the effect of omega3 on pruritus in patients under peritoneal dialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Being under maintenance dialysis for at least one month; Not being under other drug treatment for pruritus; Having pruritus for at least 8 wk; No sensitivity to omega3; Volunteer to participate. Exclusion criteria: Non compliance with drug; Renal transplantation before end of therapy; anemia (Hb<7); Hyperparathyroidism (parathormone >300 eq/ml or phosphorus >7mg/dl); PT & INR rising.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan university of Medical Sciences
Street address
Vice Chancellor for Research, Isfahan Univrsity of Medicines
City
Isfahan
Postal code
Approval date
1990-01-01, 1368/10/11
Ethics committee reference number
288273
Health conditions studied
1
Description of health condition studied
Pruritus in peritoneal Patients
ICD-10 code
N18.0
ICD-10 code description
End-stage renal disease
Primary outcomes
1
Description
Decrease in Pruritus Score
Timepoint
every 2 week
Method of measurement
visual Analog scale
Secondary outcomes
1
Description
coagulopathy
Timepoint
every month
Method of measurement
PT and INR
Intervention groups
1
Description
cap omega3 1000 mg TDS
Category
Treatment - Drugs
2
Description
placebo TDS
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra University Hospital
Full name of responsible person
Dr Mojgan Mortazavi
Street address
Internal Medicine Department, Alzahra Hospital, Soffeh Ave.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, School of Medicine, Isfahan University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research ,Dr Peiman Adibi
Street address
Vice Chancellor for Research, School of Medicine, Isfahan University of Medical Sciences, Hezar Jarib St
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, School of Medicine, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mojgan Mortazavi
Position
Associate Prof. Nephrology
Other areas of specialty/work
Street address
Internal Medicine Department, Alzahra Hospital, Soffeh Ave.
City
Isfahan
Postal code
Phone
+98 311625555
Fax
Email
m_mortazavi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mojgan Mortazavi
Position
Associate Prof. Nephrology
Other areas of specialty/work
Street address
Internal Medicine Department, Alzahra Hospital, Soffeh Ave.
City
Isfahan
Postal code
Phone
+98 311625555
Fax
Email
m_mortazavi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)