The purpose of this double blind randomized clinical trial is evaluation the effect of vitamin C and E supplementation on muscle damage, oxidative stress and performance in female athletes. In this study, 64 trained female athletes who meet inclusion criteria are randomly assigned to one of four groups, a: vitamin C (250 mg/day), b: vitamin E (400 IU) ,c: vitamin C + vitamin E and control (placebo). 10cc blood sample will be collected at the beginning and end of intervention to assess the indicators related to muscle damage(AST, CK, LDH, Mb) Indicator of oxidative stress(MDA). Harvard Step Test will be done to measure maximal oxygen consumption for performance and Food intake will be assessed by food records in first and the end intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111095062N2
Registration date:2012-10-07, 1391/07/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-10-07, 1391/07/16
Registrant information
Name
Reza Ghiasvand
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2742
Email address
ghiasvand@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-09-04, 1390/06/13
Expected recruitment end date
2011-12-11, 1390/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Vitamins C and E supplementation on muscle damage, oxidative stress and performance in athlete women
Public title
The effect of Vitamins C and E supplementation in athlete women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in the study; having 3 to 6 years experience in sports; age between 45-20 years; a complete physical health; the use of antioxidant supplements in the previous month; lack of pregnancy and lactation
Exclusion criteria: any disease occurring; occurring in pregnancy; unwillingness to continue the study; addiction to alcohol, drugs and cigarettes; less than 70% compliance
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Hezarjirib St, Isfahan University
City
Isfahan
Postal code
Approval date
2012-06-13, 1391/03/24
Ethics committee reference number
391097
Health conditions studied
1
Description of health condition studied
Sports Nutrition
ICD-10 code
Z00.8
ICD-10 code description
Other general examinations
Primary outcomes
1
Description
Myoglobin
Timepoint
Before and after Intervention
Method of measurement
ELISA, μg/L
2
Description
Aspartate Transaminase
Timepoint
Before and after Intervention
Method of measurement
Enzymatic Photometric Method, U/L
3
Description
Lactate dehydrogenase
Timepoint
Before and after Intervention
Method of measurement
Colorimetric enzymatic method, U/L
4
Description
Malondialdehyde
Timepoint
Before and after Intervention
Method of measurement
Spectrophotometry, ng/ml
5
Description
Weight
Timepoint
Early intervention
Method of measurement
Medical scales with stadiometer, Kg
6
Description
Height
Timepoint
Early intervention
Method of measurement
Medical scales with stadiometer, cm
7
Description
VO2 max
Timepoint
Before and after Intervention
Method of measurement
Harvard step test, ml.kg-1.min-1
8
Description
Creatine kinase
Timepoint
Before and after Intervention
Method of measurement
Colorimetric method, U/L
9
Description
Subcutaneous fat
Timepoint
Before and after Intervention
Method of measurement
Caliper, Percentage
Secondary outcomes
1
Description
Physical Activity
Timepoint
During the study
Method of measurement
Questionnaire-(Met.min/Week)
2
Description
Get food
Timepoint
Beginning and end of intervention (weeks 4)
Method of measurement
Questionnaire and Software N4
Intervention groups
1
Description
Group control (placebo): Consumption of both placebo vitamins with meals for a month
Category
Other
2
Description
Group3: Supplementation with 250 mg of vitamin C + vitamin supplements E 400 IU with meals for a month
Category
Other
3
Description
Group 1: Supplementation with 250 mg of vitamin C+ Placebo vitamin E with meals for a month
Category
Other
4
Description
Group 2: Supplementation with Vitamin E 400 IU +Placebo vitamin C with meals for a month
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fitness and aerobics center in Isfahan
Full name of responsible person
Dr. Daneshvar
Street address
Takhti Crossroads, Fitness and aerobics center in Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Peyman Adibi
Street address
Hezarjarib St, Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Dr.Reza Ghiasvand
Position
Ph.D. in Nutritional Sciences
Other areas of specialty/work
Street address
Hezarjarib St, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2742
Fax
Email
ghiasvand@hlth.mui.ac
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Reza Ghiasvand
Position
Ph.D. in Nutritional Sciences
Other areas of specialty/work
Street address
Hezarjarib St, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2742
Fax
Email
ghiasvand@hlth.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
Maryam Taghiyar
Position
Student
Other areas of specialty/work
Street address
Hezarjarib St, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8174673461
Phone
+98 31 1441 7961
Fax
Email
m_taghiyar1365@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)