The aim of this study was investigating effects of omega3 fatty acids supplementation on cytokines profile in pemphigus patients. 30 pemphigus patients divided into control and intervention groups. They receive respectively placebo and omega3 supplement. It is a randomized and double blind study. Exclusion criteria are: 1- Patients suffer from sever food allergy, other autoimmune diseases, cancers, kidney diseases.
2- Consuming omega 3 supplement 1mounth before starting intervention. Primary outcomes are: interleukines 1 betta and 6,TNF alpha.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012082110640N1
Registration date:2013-04-16, 1392/01/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-04-16, 1392/01/27
Registrant information
Name
Mona Zendehdel
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8253
Email address
zendehdel.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega3 supplementation on cytokines profile in Pemphigus patients.
Public title
The effect of omega3 supplemention in Pemphigus patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1- Diagnose of pemphigus by physicien.
2 -Adult male and female.
Exclusion criteria:1- Patients suffer from sever food allergy, other autoimmune diseases, cancer, kidney diseases.
2- Consuming omega 3 supplement 1 mounth before
starting intervention.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Research and technology management, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Postal code
Approval date
2012-04-20, 1391/02/01
Ethics committee reference number
eth379
Health conditions studied
1
Description of health condition studied
Pemphigus
ICD-10 code
L10
ICD-10 code description
Pemphigus neonatorum
Primary outcomes
1
Description
TNF-alpha
Timepoint
before, 1 and 3 mounths after supplementation
Method of measurement
ELISA
2
Description
Interleukine 1β
Timepoint
before, 1 and 3 mounths after supplementation
Method of measurement
ELISA
3
Description
Interleukine 6
Timepoint
before, 1 and 3 mounths after supplementation
Method of measurement
ELISA
Secondary outcomes
1
Description
Body weight
Timepoint
before,1 and 3 mounths after supplementation
Method of measurement
body weighing with digital scale
Intervention groups
1
Description
Intervention group:
Omega 3, capsule 1 gram, 3 times a day, during 3 months
Category
Treatment - Other
2
Description
Placebo group:
Paraffin, capsule 1 gram, 3 times a day, during 3 months
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mona Zendehdel
Position
MSc student/ BSc
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan blvd.
City
Ahvaz
Postal code
Phone
+98 61 1373 8253
Fax
Email
m.zendehdel@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mona Zendehdel
Position
BSc
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences,Golestan blvd.
City
Ahvaz
Postal code
Phone
+98 61 1373 8253
Fax
Email
m.zendehdel@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mona Zendehdel
Position
BSc
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan blvd.
City
Ahvaz
Postal code
Phone
+98 61 1373 8253
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)