The effect of alpha-lipoic acid supplementation on hs-CRP, interleukin-6, body weight and hypertention in male patients with chronic spinal cord injury
object:The effect of alpha-lipoic acid supplementation on hs-CRP, interleukin-6, body weight and hypertention in male patients with spinal cord injury
This is a randomized, double-blind, placebo-controlled, single centerstudy in the 2-3 phase of clinical trial.
inclusion criteria: male; spinal cord injury for at least a year and the maximum is 10 years past the onset of disease; BMI>=18.5; Complete spinal cord injury (lack of motor function below the lesion); age between 30-50 years; informed consent; Lack of specific diseases and malignancies such as liver disease; kidney disease and cancer;
Exclusion criteria: not wanting Collaboration; Failure to follow the program of receiving supplements (less than 80%); changes in food pattern ; certain diseases and malignancies during study; Use of antioxidant supplements of at least one month prior to study entry and during study
70 Eligible patients divided into two groups, intervention and placebo and take 600 mg Alpha Lipoic Acid and placebo for 12 weeks respectively.
we expect changes in levels of hs-CRP, IL-6, weight, blood pressure, blood sugar and dietary intake in the intervention group than baseline and the placebo group before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106122602N6
Registration date:2012-05-06, 1391/02/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-05-06, 1391/02/17
Registrant information
Name
Shahryar Eghtesadi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 9118
Email address
egtesadi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-05-09, 1391/02/20
Expected recruitment end date
2012-10-21, 1391/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of alpha-lipoic acid supplementation on hs-CRP, interleukin-6, body weight and hypertention in male patients with chronic spinal cord injury
Public title
The effect of alpha-lipoic acid supplementation on hs-CRP, interleukin-6, body weight and hypertention in male patients with chronic spinal cord injury
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: male; spinal cord injury for at least a year and the maximum is 10 years past the onset of disease; BMI>=18.5; Complete spinal cord injury (lack of motor function below the lesion); age between 30-50 years; informed consent; Lack of specific diseases and malignancies such as liver disease; kidney disease and cancer;
Exclusion criteria: no Collaboration; Failure to follow the program of receiving supplements (less than 80%); changes in food pattern ; certain diseases and malignancies during study; Use of antioxidant supplements of at least one month prior to study entry and during study
Age
From 30 years old to 50 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Tehran University of Medical Sciences
Street address
Sixth Floor,Central Organization of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd
City
Tehran
Postal code
Approval date
2012-04-15, 1391/01/27
Ethics committee reference number
2623/130/د/90
Health conditions studied
1
Description of health condition studied
Chronic spinal cord injery
ICD-10 code
TO9.3
ICD-10 code description
Injury of spinal cord, level unspecified
Primary outcomes
1
Description
hs-CRP
Timepoint
Before and after intervention
Method of measurement
ELISA
2
Description
IL-6
Timepoint
Before and after intervention
Method of measurement
ELISA
3
Description
weight
Timepoint
Before and after intervention
Method of measurement
Wheelchair scales
4
Description
Waist circumference
Timepoint
Before and after intervention
Method of measurement
Meter
5
Description
Systolic blood pressure
Timepoint
Before and after intervention
Method of measurement
Mercury barometer
6
Description
Diastolic blood pressure
Timepoint
Before and after intervention
Method of measurement
Mercury barometer
7
Description
FBS
Timepoint
Before and after intervention
Method of measurement
Colorimetric autoanalyzer
8
Description
Energy intake
Timepoint
Before and after intervention
Method of measurement
recall
9
Description
Carbohydrates intake
Timepoint
Before and after intervention
Method of measurement
recall
10
Description
Protein intake
Timepoint
Before and after intervention
Method of measurement
recall
11
Description
fat intake
Timepoint
Before and after intervention
Method of measurement
recall
12
Description
BMI
Timepoint
Before and after intervention
Method of measurement
mathematics
Secondary outcomes
1
Description
vitamin C
Timepoint
before and after intervention
Method of measurement
recall
2
Description
vitamin E
Timepoint
before and after intervention
Method of measurement
recall
Intervention groups
1
Description
alpha- lipoic acid, capsule 600 mg, once a day for 12 weeks