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The effect of alpha-lipoic acid supplementation on some cardiovascular indicators, inflammatory markers, and lipid profile in patients with stroke

Protocol summary

Summary
aim: The effect of alpha-lipoic acid supplementation on some cardiovascular indicators, inflammatory markers, and lipid profile in patients with stroke Study design: double blind, randomized and placebo-controlled clinical trial, Inclusion criteria: patients with thrombotic and embolic stroke; NIHS Score = 5-24 ; age 30 to 70 years; BMI in the range of 18.5-35. exclusion criteria: unwillingness to continue; recurrent stroke during the study; death. Sample size: 80 Intervention: 600mg lipoic acid or placebo for 12 weeks Primary outcomes: Carotid Intima Media Thickness, Flow Mediated Dilation, Interleukin -6, Tumor Necrosis Factor-alpha, hs-CRP, systolic and diastolic blood pressure, triglycerides, total cholesterol, LDL- cholesterol, HDL- cholesterol, Fasting Blood Suger, fasting insulin

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016051811763N23
Registration date: 2016-06-29, 1395/04/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-06-29, 1395/04/09
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research, Isfahan university of Medical sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of alpha-lipoic acid supplementation on some cardiovascular indicators, inflammatory markers, and lipid profile in patients with stroke
Public title
The effect of lipoic acid supplementation on stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with thrombotic and embolic stroke ; NIHS Score = 5-24 ; age 30 to 70 years; BMI in the range of 18.5-35. exclusion criteria: unwillingness to continue; recurrent stroke during the study; death.
Age
From 30 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Isfahan university of Medical sciences
Street address
Vice president of research-Isfahan university of Medical sciences- Hezarjarib street- Isfahan
City
Isfahan
Postal code
Approval date
2016-05-09, 1395/02/20
Ethics committee reference number
IR.MUI.REC.1395.3.068

Health conditions studied

1

Description of health condition studied
strok
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction

Primary outcomes

1

Description
carotid intima media thickness
Timepoint
Before and 12 weeks after intervention
Method of measurement
sonography doppler

2

Description
flow mediated dilation
Timepoint
Before and 12 weeks after intervention
Method of measurement
sonography doppler

3

Description
TNF-α
Timepoint
Before and 12 weeks after intervention
Method of measurement
ELISA

4

Description
IL-6
Timepoint
Before and 12 weeks after intervention
Method of measurement
ELISA

5

Description
hs-CRP
Timepoint
Before and 12 weeks after intervention
Method of measurement
ELISA

6

Description
TG
Timepoint
Before and 12 weeks after intervention
Method of measurement
kit

7

Description
total cholesterol
Timepoint
Before and 12 weeks after intervention
Method of measurement
Enzymatic

8

Description
LDL
Timepoint
Before and 12 weeksafter intervention
Method of measurement
Friedewald

9

Description
HDL
Timepoint
Before and 12 weeks after intervention
Method of measurement
Spectrophotometry

10

Description
Fasting blood glucose
Timepoint
Before and 12 weeks after intervention
Method of measurement
Spectrophotometry

11

Description
fasting insulin
Timepoint
Before and 12 weeks after intervention
Method of measurement
ELISA

12

Description
systolic blood pressur
Timepoint
Before and 12 weeks after intervention
Method of measurement
Mercury manometers

13

Description
diastolic blood pressur
Timepoint
Before and 12 weeks after intervention
Method of measurement
Mercury manometer

Secondary outcomes

1

Description
carotenoids intake
Timepoint
before and 12 weeks after intervention
Method of measurement
24 food recall

2

Description
weight
Timepoint
before and 12 weeks after intervention
Method of measurement
seca balance

3

Description
waist circumference
Timepoint
before and 12 weeks after intervention
Method of measurement
tape

4

Description
energy intake
Timepoint
before and 12 weeks after intervention
Method of measurement
24 food recall

5

Description
carbohydrate intake
Timepoint
before and 12 weeks after intervention
Method of measurement
24 food recall

6

Description
fat intake
Timepoint
before and 12 weeks after intervention
Method of measurement
24 food recall

7

Description
protein intake
Timepoint
before and 12 weeks after intervention
Method of measurement
24 food recall

8

Description
vitamin E intake
Timepoint
before and 12 weeks after intervention
Method of measurement
24 food recall

9

Description
vitamin C intake
Timepoint
before and 12 weeks after intervention
Method of measurement
24 food recall

Intervention groups

1

Description
lipoic acid 600 mg
Category
Treatment - Drugs

2

Description
corn starch 600 mg
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Al Zahra Hospital
Full name of responsible person
Vida Mohammadi
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice President of Research, Isfahan University of Medical Sciences
Full name of responsible person
Amirmansour Alavi
Street address
Hezarjarib street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of 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 University of Medical Sciences
Full name of responsible person
Vida Mohammadi
Position
PhD candidate
Other areas of specialty/work
Street address
Hezarjarib streetو Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 3171
Fax
Email
Mohammadi_vida@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan university of Medical sciences
Full name of responsible person
Gholam Reza Askari
Position
PhD of Nutrition sciences
Other areas of specialty/work
Street address
Hezarjarib street, Isfahan university of Medical sciences
City
Isfahan
Postal code
Phone
+98 31 3792 3171
Fax
Email
askari@mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan university of medical sciences
Full name of responsible person
Vida Mohammadi
Position
PhD candidate
Other areas of specialty/work
Street address
Hezarjarib street, Isfahan university of medical sciences
City
Isfahan
Postal code
Phone
+98 31 3792 3171
Fax
Email
mohammadi_vida@yahoo.com
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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