Objectives: This study conducted to evaluate the effect of omega 3 fatty acid (fish oil) on serum levels of inflammatory factors such as TNF-α, hs_CRP and ESR in patients with hashimoto thyroiditis. Design: A randomized, double-blind, placebo-controlled clinical trial was conducted on 60 hashimoto patients who referred to Urmia Emam KHomeini Hospital. Setting and conduct: Patients were divided randomly into 2 groups; intervention group received 3 grams per day omega-3 supplement and placebo group tablets containing 3 grams edible paraffin 3 times in a day for 8 weeks. Participants: inclusion criteria were Hashimoto patients over 18 years. Exclusion criteria including: patients with rheumatoid arthritis; celiac disease; pernicious anemia; systematic lupus erythematous and other autoimmune disease and other acute or chronic infections disease; postmenopausal women; pregnant and Lactating women; taking drugs such as warfarin; aspirin; gamma interferon; smoking; using contraceptive drugs; Seasonal allergies; allergy to the fish or oil fish; eating fish over twice in week. TNF-α, hs_CRP and ESR before and after 8 weeks intervention were compared between two groups. The 24-hour dietary recall questionnaire was filled for participants in before and after the intervention duration.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050629508N6
Registration date:2017-07-06, 1396/04/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-06, 1396/04/15
Registrant information
Name
Rasoul Zarrin
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9935
Email address
rasoul.zarrin@uqconnect.edu.au
Recruitment status
Recruitment complete
Funding source
by my own
Expected recruitment start date
2016-09-24, 1395/07/03
Expected recruitment end date
2017-03-05, 1395/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of omega 3 fatty acid (fish oil) on serum levels of inflammatory factors in patients with hashimoto thyroiditis
Public title
Evaluation of the effect of omega 3 fatty acid in patients with hashimoto thyroiditis
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Hashimoto patients over 18 years. Exclusion criteria: patients with rheumatoid arthritis; celiac disease; pernicious anemia; Systematic lupus erythematous and other autoimmune disease and other acute or chronic infections disease; postmenopausal women; pregnant and lactating women; taking drugs such as warfarin; aspirin; gamma interferon; smoking; using contraceptive drugs; Seasonal allergies; allergy to the fish or oil fish; eating fish over twice in week.
Age
From 17 years old to 70 years old
Gender
Female
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
Parallel
Other design features
This study was conducted as double-blind. The researcher and participants were unaware that patients randomized in which groups (the intervention or placebo).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat Ave, Urmia, Iran
City
Urmia
Postal code
Approval date
2016-11-16, 1395/08/26
Ethics committee reference number
IR.UMSU.REC.1395.306
Health conditions studied
1
Description of health condition studied
hashimoto disease
ICD-10 code
E06.3
ICD-10 code description
Autoimmune thyroiditis
Primary outcomes
1
Description
TNF-α (tumor necrosis factor alpha)
Timepoint
before and 8 week after intervention
Method of measurement
laboratory kit
2
Description
ESR (erythrocyte sedimentation rate)
Timepoint
before and 8 week after intervention
Method of measurement
laboratory kit
3
Description
hs_CRP (high-sensitivity C-reactive protein)
Timepoint
before and 8 week after intervention
Method of measurement
laboratory kit
Secondary outcomes
1
Description
24 hour recall
Timepoint
before and 8 week after intervention
Method of measurement
24 hour recall questioniare
Intervention groups
1
Description
Intervention group: received omega-3 supplement for 8 weeks 3 grams per day in three divided doses (one pill three times a day after meals) containing 180mg eicosapentaenoic acid and 120mg docosahexaenoic acid
Category
Other
2
Description
Placebo group: took placebo pills containing edible paraffin 3 times in a day for 8 weeks