The Comparison of The Effect of Eicosapentaenoic Acid and Docosahexaenoic Acid on Helicobacter pylori Infection Eradication and Some Serum Inflammatory Factors
The objective of this study is to compare the effect of Eicosapentaenoic Acid and Docosahexaenoic Acid on Helicobacter pylori infection eradication and some serum inflammatory factors. In this double blind placebo controlled randomized clinical trial, 105 patients with Helicobacter pylori infection, without history of infection & pharmaceutical treatment, will be selected and received pharmaceutical treatment of infection eradication for 2 weeks. For another 10-week period (totally 12 weeks), the patients in the control group received 2 gr MCT placebo daily, in the second group received 2 gr moreEPA supplement daily and the patients in the third group received 2 gr moreDHA supplement daily. After 12 weeks, infection eradication rate and level of serum inflammatory factors such as hs-CRP, Il-6, Il-8, and TAC will be measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101122709N16
Registration date:2011-02-13, 1389/11/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-02-13, 1389/11/24
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Faculty of Public Health of Tehran University of Medical Sciences
Expected recruitment start date
2011-01-30, 1389/11/10
Expected recruitment end date
2011-05-31, 1390/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of The Effect of Eicosapentaenoic Acid and Docosahexaenoic Acid on Helicobacter pylori Infection Eradication and Some Serum Inflammatory Factors
Public title
The Comparison of The Effect of Eicosapentaenoic Acid and Docosahexaenoic Acid on Helicobacter pylori Infection Eradication and Some Serum Inflammatory Factors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- positive stool antigen test result
- no history of pharmaceutical treatment for infection eradication
- no gastric surgery
- no history of peptic ulcer
- no any disease that cause inflammation & increase of serum inflammatori markers level such as diabetes, CVD, respiratoryinflammations such as asthma,...
- no consumption of any drug other than prescribed drugs during the study
- no consumption of antibiotic or bismut during 2 months before the trial
- no consumption of antioxidant supplements such as Se, Zn, beta-caroten,... at least 3 months before the trial
- no consumption of omega-3 supplements at least 3 months before the trial
- no smoking
- BMI less than 30
- age between 20-60 years old
-leaning to cooperation
Exclusion criteria:
- no leaning to continuing the cooperation
- any change in type or dose of prescribed drugs
- any change in daily diet or physical activity
- consumption of any antioxidant supplement
- consumption of less than 70% of supplements given to patients at the start of the study
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
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
Faculty of Public Health of Tehran University of Medical Sciences
Street address
Number 60, Alvand street, Argentina square, Tehran
City
Tehran
Postal code
1516846515
Approval date
2010-10-10, 1389/07/18
Ethics committee reference number
2402
Health conditions studied
1
Description of health condition studied
Helicobacter pylori
ICD-10 code
K25
ICD-10 code description
Primary outcomes
1
Description
Helicobacter pylori infection eradication
Timepoint
before & after intervention (after 12 weeks intervention)
Method of measurement
stool antigen test
2
Description
serum level of Il-6
Timepoint
before & after intervention (after 12 weeks intervention)
Method of measurement
ELISA kitt
3
Description
serum level of Il-8
Timepoint
before & after intervention (after 12 weeks intervention)
Method of measurement
ELISA kitt
4
Description
serum level of hs-CRP
Timepoint
before & after intervention (after 12 weeks intervention)
Method of measurement
ELISA kitt
5
Description
serum level of TAC
Timepoint
before & after intervention (after 12 weeks intervention)
Method of measurement
colorimetry (FRAP)
Secondary outcomes
empty
Intervention groups
1
Description
control group : MCT supplement, 2 grams per day (twice a day, each time 1 gram), at morning and evening, and during 12 weeks
Category
Placebo
2
Description
intervention 1 group : moreEPA supplement, 2 gram per day (twice a day, each time 1 gram) at morning and evening, and during 12 weeks
Category
Treatment - Drugs
3
Description
intervention 2 group:moreDHA supplement, 2 grams per day (twice a day, each time 1 gram), at morning and evening, and during 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Honor Rasool Akram therapeutic educational center
Full name of responsible person
Dr Shahram Agah
Street address
Sttar khan - Niyayesh street
City
Tehran
2
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Dr Shahram Agah
Street address
Valiasr square - Behafarin street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vive-chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr Seyyed Abbas Motevalian
Street address
Keshavarz Bld - intersection of Qods street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vive-chancellor for Research, Tehran University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Gastrointestinal & Liver Disease Research Center (Firoozgar GILDRC)
Full name of responsible person
Dr Shahram Agah
Street address
Valiasr square - Behafarin street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gastrointestinal & Liver Disease Research Center (Firoozgar GILDRC)
Proportion provided by this source
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
Faculty of Public Health of Tehran University of Medical Sciences
Full name of responsible person
Dr Farzad Shidfar
Position
Professor /nutrition PhD
Other areas of specialty/work
Street address
Number 60, Alvand street, Argentina square, Tehran
City
Tehran
Postal code
1516846515
Phone
+98 21 8877 9118
Fax
+98 21 8877 9487
Email
farzadshidfar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Public Health of Tehran University of Medical Sciences
Full name of responsible person
Dr Farzad Shidfar
Position
Professor /nutrition PhD
Other areas of specialty/work
Street address
Number 60, Alvand street, Argentina square, Tehran
City
Tehran
Postal code
1516846515
Phone
+98 21 8877 9118
Fax
+98 21 8877 9487
Email
farzadshidfar@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)