Effect of vitamin E and C supplements on lipid peroxidation and GSH-dependent antioxidant enzymes status in the blood of women consuming oral contraceptives
Combined oral contraceptive pills (COCP) are birth prevention pills consisting estrogen and progesterone. The aim of the present prospective study was to investigate whether supplementation of vitamins C and E reduce the some side effects of COCPs. Stress oxidative in 120 healthy premenopausal (three groups) women with regular menstrual cycles, that come for family planning into health centers, would be assayed.
Participants are Iranian women aged 18-40 years who use COC pills for birth control. They use COC for at least 1 year and maximum 10 years. Exclusion criteria are hormonal treatment during the last 3 months, smoking, treatment with vitamin preparations or some drugs, alcohol abuse, and the need for regular medication. In the present study we examine the effects of OC alone and with vitamin E and C supplementation on the plasma glutathione (GSH)-dependent antioxidant system and also lipid peroxidation levels in women taking the OC. Therefore, malondialdehyde (MDA) level and glutathione peroxidase (GPx) and glutathione reductase (GR) activity will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109267641N1
Registration date:2011-10-31, 1390/08/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-31, 1390/08/09
Registrant information
Name
Fatemeh Zal
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1230 3029
Email address
zalf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz university of medical sceinces
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2011-11-22, 1390/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin E and C supplements on lipid peroxidation and GSH-dependent antioxidant enzymes status in the blood of women consuming oral contraceptives
Public title
Using antioxidants with oral contraceptives
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Iranian; age between 18-40; body mass index (BMI) 19-25; not using other supplement drugs and vitamin during the previous 3 months; not using cigarette and alcohol; not using special drugs; not having any known disease; using contraceptive pills for at least 1 and maximum 10 years; not having breast feeding. Excluding criteria: some special disease during study; changing the pregnancy prevention way during study; exit from study or immigration.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz university of medical sceinces
Street address
Zand street
City
Shiraz
Postal code
Approval date
2011-09-03, 1390/06/12
Ethics committee reference number
CT-90-5655
Health conditions studied
1
Description of health condition studied
oral contraceptive pill taking
ICD-10 code
Y42.4
ICD-10 code description
Oral contraceptives
Primary outcomes
1
Description
lipid peroxidation
Timepoint
one time and 1 month after ocp taking
Method of measurement
photometery
Secondary outcomes
1
Description
antioxidant enzymes
Timepoint
one time 1 month after ocp taking
Method of measurement
photometery
Intervention groups
1
Description
150 mg of vitamin C and 200 IU vitamin E for 4 weeks
Category
Treatment - Drugs
2
Description
no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health care centers of Shiraz university of medical sciences
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Dr. Poost forush
Street address
Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz university of medical sciences
Full name of responsible person
Dr. Fatemeh Zal
Position
PhD/ assistant professor of biochemistry
Other areas of specialty/work
Street address
Biochemistry department, Medical school, Zand street
City
Shiraz
Postal code
Phone
+98 71 1230 3029
Fax
Email
zalf@sums.ac.irfatemehzal@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Dr. Fatemeh Zal
Position
PhD/assistant professor of biochemistry
Other areas of specialty/work
Street address
Biochemistry department, Medical school, Zand street
City
Shiraz
Postal code
Phone
+98 71 1230 3029
Fax
Email
fatemehzal@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)