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Comparing the effect of vitamin E and n_3 PUFA supplementation on insulin resistance syndrome indices in children and adolescents.

Protocol summary

Summary
This study is destined to elucidate the effects of vitamin E and n_3 PUFA supplementation on insulin resistance syndrome indices in children and adolescence. We conducted an 8 weeks, randomized, triple blind clinical trial on 90 patients with diagnosed metabolic syndrome, being between 10-18 years old in Cardiovascular Research Center of Isfahan University of Medical Sciences. They are divided into 3 groups, each containing 30 patients. One group receives vitamin E tablets (400 IU/day), another group receives Omega-3 supplementation (2gr/day) and the other one receives placebo. All groups are given similar, appropriate exercise and diet plan during study. Insulin resistance syndrome indices as well as secondary outcomes such as total cholesterol, LDL, NO, VEGF, Fasting serum insulin level, antioxidant capacity, HOMA-IR and hs-CRP will be measured before and after this 8-week period and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138708151434N1
Registration date: 2009-10-28, 1388/08/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2009-10-28, 1388/08/06
Registrant information
Name
Roya Kelishadi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 3060
Email address
kelishadi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2008-12-31, 1387/10/11
Expected recruitment end date
2009-12-31, 1388/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of vitamin E and n_3 PUFA supplementation on insulin resistance syndrome indices in children and adolescents.
Public title
Comparing the effect of vitamin E and Omega-3 fatty acids on metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Matching metabolic syndrome definition (based on the new definition of International Diabetes Federation (IDF) on October 2007) (The IDF consensus definition for children 10 to <16 years of age include the clustering of any three of the following risk factors: 1) obesity, waist circumference ≥ 90% based on age and gender; 2) triglycerides ≥ 150 mg/dL; 3) HDL- cholesterol < 40 mg/dL; 4) systolic blood pressure ≥ 130/ diastolic blood pressure ≥ 85 mmHg and 5) glucose ≥ 100 mg/dL. For individuals over 16 years old, the adult definition should be applied.), undergoing at least 4 months of common therapies without significant response. Exclusion criteria: Possible drug side effects, no compliance for follow up
Age
From 10 years old to 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan Cardiovascular Research Center, Isfahan University of Medical Sciences
Street address
Khorram St., Isfahan, Iran
City
Isfahan
Postal code
Approval date
2007-03-10, 1385/12/19
Ethics committee reference number
387198

Health conditions studied

1

Description of health condition studied
Metabolic Syndrome
ICD-10 code
E78.8
ICD-10 code description
Other disorders of lipoprotein metabolism

Primary outcomes

1

Description
Waist circumference
Timepoint
At the beginning of the study and 8 weeks after intervention.
Method of measurement
Non elastic tape with accuracy of 0.1 cm

2

Description
Weight
Timepoint
at the beginning of the study and 8 weeks after intervention
Method of measurement
SECA medical scale with the accuracy of o.1 kg

3

Description
Height
Timepoint
at the beginning of the study
Method of measurement
SECA stadiometer with the accuracy of 0.1 cm

4

Description
Triglycerides(TG)
Timepoint
At the beginning of the study and 8 weeks after intervention.
Method of measurement
Enzymatic

5

Description
Blood pressure
Timepoint
At the beginning of the study and 8 weeks after intervention.
Method of measurement
Mercury sphygmomanometer wit the accuracy of 1mmHg

6

Description
High-density lipoprotein (HDL)
Timepoint
At the beginning of the study and 8 weeks after intervention.
Method of measurement
Enzymatic

7

Description
Fasting Blood Sugar(FBS)
Timepoint
At the beginning of the study and 8 weeks after intervention.
Method of measurement
Glucose Oxidase method

8

Description
BMI
Timepoint
At the beginning of the study and 8 weeks after intervention.
Method of measurement
calculated by the formula:weight/height2(kg/m2)

Secondary outcomes

1

Description
Total cholesterol
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
Enzymatic

2

Description
Low Density Lipoprotein(LDL)
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
Directly

3

Description
Nitric Oxide(NO)
Timepoint
At the begining of intervention and 8 weeks later
Method of measurement
ELISA

4

Description
Vascular Endothelial Growth Factor(VEGF)
Timepoint
At the begining of intervention and 8 weeks later
Method of measurement
Sandwich ELISA method

5

Description
Fasting Insulin
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
ELISA

6

Description
Total Anti Oxidant Capacity in Plasma
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
calorimetery

7

Description
HOMA-IR
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
calculation

8

Description
hs-CRP
Timepoint
At the beginning of the study and 8 weeks after intervention
Method of measurement
Immunoturbidimetry

Intervention groups

1

Description
Omega-3 Capsule, 2000 mg ( containing 600 mg EPA/DHA) once daily for 8 weeks
Category
Treatment - Drugs

2

Description
Vitamin E capsule, 400 IU once daily for 8 weeks
Category
Treatment - Drugs

3

Description
Placebo capsule once daily for 8 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Cardiovascular Research Center
Full name of responsible person
Roya Kelishadi, MD
Street address
Khorram St.
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellery for Research, Isfahan University of Medical Sciences
Full name of responsible person
Peyman Adibi, MD
Street address
Hezar Jarib St.
City
Isfahan
Grant name
Grant code / Reference number
387198
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellery 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 Cardiovascular Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Roya Kelishadi
Position
Associate Professor
Other areas of specialty/work
Street address
Khorram St.
City
Isfahan
Postal code
Phone
+98 31 1337 7881
Fax
+98 31 1337 3435
Email
kelishadi@med.mui.ac.ir
Web page address
www.crc.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan Cardiovascular Research Center, Isfahan University of Medical Sciences
Full name of responsible person
Roya Kelishadi
Position
Associate Professor
Other areas of specialty/work
Street address
Khoram st., Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1337 7881
Fax
Email
kelishadi@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Roya Kelishadi, MD
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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