The comparison of the effect of eicosapentaenoic acid and docosahexaenoic acid on lipoprotein profile & tumor necrosis factor-α in patients with helicobacter pylori Infection
The objective of this study is to compare the effect of Eicosapentaenoic Acid and Docosahexaenoic Acid on serum lipoprotein profile. 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, level of serum TC, LDL-C, HDL-C, TG & TNF-alfa will be measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205262709N25
Registration date:2012-07-07, 1391/04/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-07, 1391/04/17
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
Gastrointestinal & Liver Disease Research Center of Tehran University of Medical Sciences- Firoozgar
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-09-20, 1391/06/30
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 lipoprotein profile & tumor necrosis factor-α in patients with helicobacter pylori Infection
Public title
The comparison of the effect of eicosapentaenoic acid and docosahexaenoic acid in patients with helicobacter pylori infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: positive helicobacter pylori 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 inflammatory 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
School of Public Health of Tehran of University of Medical Sciences
Street address
Number 60, Alvand Street, Argentina Square
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
k27
ICD-10 code description
Peptic ulcer, site unspecified
Primary outcomes
1
Description
total cholesterol
Timepoint
before & after intervention (after 12 weeks intervention)
Method of measurement
enzymatic colorimetry
2
Description
LDL-C
Timepoint
before & after intervention (after 12 weeks intervention)
Method of measurement
immunotorbidometry
3
Description
HDL-C
Timepoint
before & after intervention (after 12 weeks intervention)
Method of measurement
immunotorbidometry
4
Description
TG
Timepoint
before & after intervention (after 12 weeks intervention)
Method of measurement
colorimetry
5
Description
TNF-alfa
Timepoint
before & after intervention (after 12 weeks intervention)
Method of measurement
enzymatic colorimetry
Secondary outcomes
empty
Intervention groups
1
Description
intervention 1 group : daily 2 gr morEPA supplement during 12 weeks
Category
Treatment - Drugs
2
Description
intervention 2 group : daily 2 gr morDHA supplement during 12 weeks
Category
Treatment - Drugs
3
Description
control group : daily 2 gr MCT placebo during 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram hospital
Full name of responsible person
Dr Shahram Agah
Street address
Niyayesh street, Sttar khan street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gastrointestinal & Liver Disease Research Center (Firoozgar GILDRC)
Full name of responsible person
Dr Shahram Agah
Street address
Behafarin street, Valiasr square
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
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
School of Public Health of Tehran University of Medical Sciences
Full name of responsible person
Dr Farzad Shidfar
Position
Professor Assistant/nutrition PhD
Other areas of specialty/work
Street address
Number 60,The end of Alvand Street, Argentina square
City
Tehran
Postal code
1516846515
Phone
+98 21 8877 9118
Fax
Email
farzadshidfar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Public Health of Tehran University of Medical Sciences
Full name of responsible person
Dr Farzad Shidfar
Position
Professor Assistant/nutrition PhD
Other areas of specialty/work
Street address
Number 60,The end of Alvand street, Argentina square
City
Tehran
Postal code
1516846515
Phone
+98 21 8877 9118
Fax
Email
farzadshidfar@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)