End stage renal disease (ESRD) is a condition that patients complaint from pruritus due to toxins accumulation. The aim of this study is to investigate the effects of dietary Omega-3 fatty acid supplementation on pruritus scale and serum level of Prostaglandin E2 in hemodialysis patients. 40 hemodialysis patients who were on hemodialysis (more than 3 months), suffering pruritus for more than eight weeks, and no history of skin diseases leading to pruritus before renal failure were enrolled. Patients with anemia (Hb<7g/dL), hyperphosphatemia (p>7mg/dL), PTH>300 microg/L, anticoagulants use, allergic reaction to omega-3 and gastrointestinal complications (e.g. diarrhea for more than two weeks) were excluded. The patients were randomly assigned to two groups of omega-3-placebo (20 patients) and placebo-omega-3 (20 patients). Patients in first group, consumed fish oil capsules (1000mg, three times a day, manufactured by Zahravi Pharmaceutical) for 4 weeks and after a 6 weeks washout period, they took placebo for another 4 weeks. The same was performed in second group, but in the reverse order. Pruritus score was evaluated each 2 weeks and serum levels of Prostaglandin E2 was recorded at the beginning and end of each treatment period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311152417N14
Registration date:2016-10-03, 1395/07/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-03, 1395/07/12
Registrant information
Name
Firouzeh Moeinzadeh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 5555
Email address
moinzade@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Omega-3 on pruritus scale in hemodialysis patients
Public title
Effect of Omega-3 on pruritus scale in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: consent for cooperation; hemodialysis for at least 3 months; pruritus duration > 8 weeks; without any dermatologic problems; no hypersensitivity to omega-3; no malabsorption or other gastrointestinal problems (chronic diarrhea >2 weeks); not using anticoagulant and antiplatelet drugs.
Exclusion criteria: incompliance; kidney transplantation; antihistamin or Gabapentin using; anemia (Hb<7g/dL ); PTH > 300microg/L ; Phosphorus >7mg/dL ; INR rising
Age
From 16 years old to 99 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Vice Chancellor for Research, Isfahan University of Medical Sciences
Street address
Hezar jarib street
City
Isfahan
Postal code
Approval date
2013-07-06, 1392/04/15
Ethics committee reference number
392301
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.0
ICD-10 code description
End Stage Renal Disease
Primary outcomes
1
Description
Pruritus score
Timepoint
At the begining, every 2 weeks and end of study
Method of measurement
Questionaire (visual analog scale)
2
Description
Serum Prostaglandin E2
Timepoint
At the begining and end of study
Method of measurement
ELISA Kit,
Secondary outcomes
empty
Intervention groups
1
Description
Cap Omega-3 1000mg, 3 capsules per day for 2 months manufactured by Zahravi company
Category
Treatment - Drugs
2
Description
Cap placebo, 3 capsules per day for 2 months manufactured by Zahravi company
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nour Hospital, Hemodialysis centre
Full name of responsible person
Dr Masoud Moghtaderi
Street address
Ostandari Street
City
Isfahan
2
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Dr. Masoud Moghtaderi
Street address
Ibne Sina Street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancell for Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Peyman Adibi
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancell for Research, 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. Masoud Moghtaderi
Position
Internal medicine resident
Other areas of specialty/work
Street address
Alzahra hospital, Sofe street
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
mmoghtaderi@yahoo.com
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 Professor of Nephrology
Other areas of specialty/work
Street address
Alzahra hospital, Sofe street
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
m_mortazavi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Firouzeh Moeinzadeh
Position
Assistant professor of Nephrology
Other areas of specialty/work
Street address
Alzahra hospital, Sofe street
City
Isfahan
Postal code
Phone
+98 31 1625 5555
Fax
Email
moinzade@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)