Objectives: To determine the serum levels of oxidative stress biomarkers (TAC-ROS-MDA) and pelvic pain in intervention and placebo groups. Design: Thirty women at age 49-15 years old, married, with clinical symptoms of endometriosis participate in each group. This study is randomized and triple-blind sampling. Criteria: Patients who not receive any supplementation in the last six month and without any pelvic inflammatory disease history. The exclusion criteria are unwillingness of the patient and pregnancy. Intervention: Patients have a random number from 1 to 60 and then persons divide two groups (odd and even). All patients fill the questionnaire form and 10 ml blood collect from them to measure serum level of oxidative stress biomarkers and Vit E vitamin E Before the intervention at Sarem Hospital Research Center. Patients receive vitamin E (400 units) twice daily (800 IU) and vitamin C tablets 500 mg twice daily (1000 mg) for eight week duration. They dived two groups (A and B) and after 8 weeks second blood samples collect. The questionnaire visual analogue scale (VAS) form fill by volunteers before, every 2 weeks and in final. Main outcome measures: Primary variable outcome is oxidative stress biomarkers that measure before and two month after intervention. Secondary outcome variable is pelvic pain that evaluate 2 weeks by visual analogue scale instruments.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106296917N1
Registration date:2015-10-12, 1394/07/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-12, 1394/07/20
Registrant information
Name
Leila Amini
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 3316 6574
Email address
l-amini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Unit, School of Nursing and Midwifery, Iran;
Cellular and Molecular Sciences of Sarim Hospital
Expected recruitment start date
2015-06-21, 1394/03/31
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of vitamin E and C supplements on serum levels of biomarkers of oxidative stress and pelvic pain in women with endometriosis symptoms
Public title
The impact of vitamins and antioxidants on the severity of endometriosis, pelvic pain in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No current infection or a history of pelvic inflammatory disease during the study; Adenomyosis of disease, lack of supplementation in the last six months, not smoking, alcohol, lack of underlying chronic disease or mental illness known to his remarks patient, not a specific diet) such as a vegetarian diet); women with dysmenorrhea, irregular menstruation, lack of passing clots during menstruation.
Exclusion criteria from the study:
The patient's unwillingness to continue the research, side effects and drug allergy (such as fatigue, headache, blurred vision, nausea, diarrhea), the occurrence of pregnancy, diagnosed in the laparoscopy Adenomyosis
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
By random method of packaging the door closed, that even numbers in a group and odd numbers in another group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Intersection of Sheikh Fazlollah Nouri and Shahid Chamran, Shahid Hemat Highway
City
Tehran
Postal code
Approval date
2015-04-04, 1394/01/15
Ethics committee reference number
19/ 105/ د / 94
Health conditions studied
1
Description of health condition studied
endometriosis
ICD-10 code
n80
ICD-10 code description
n80.9
Primary outcomes
1
Description
Bio-markers of oxidative stress
Timepoint
Two months before the intervention and after intervention
Method of measurement
Biomarker of oxidative stress in vitro assay kit
Secondary outcomes
1
Description
Severe pelvic pain
Timepoint
bi-weekly
Method of measurement
Visual analogue instruments
Intervention groups
1
Description
Intervention group 1: In this study, the purpose of oral administration of vitamin E 800 units (two tablets of 400 IU) twice a day for 8 weeks and vitamin c tablets a day to 1000 mg (4 tablets of 250 mg) 4 times day for 8 weeks.
Category
Placebo
2
Description
Control group: Taking 2 pills placebo vitamin E (400 IU) and 800 units of 4 placebo vitamin C (250 mg), a total of 1000 mg daily for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Women Clinic of Sarem Hospital
Full name of responsible person
Dr. Arash Poladi Research Assistant Department of Cellular and Molecular Sarem Hospital
Street address
Women Clinic of Sarem Hospital, Shahrak Ekbatan, Azadi Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences- Sarem Hospital
Full name of responsible person
Vice Chancellor for research of Sarem Hospital
Street address
Research Section of Sarem Hospital, Shahrak Ekbatan, Azadi Square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences- Sarem Hospital
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
Iran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
chekini razieh
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Iran University of Medical Science, Rashid Yasemi street, Vanak Square
City
Tehran
Postal code
Phone
+98 21 8888 2886
Fax
Email
r.chekini@gmail .com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Dr Leila Amini
Position
Ph.D. in Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasemi Street, Vanak square
City
Tehran
Postal code
Phone
+98 21 8888 2886
Fax
Email
l-amini@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
chekini razieh
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Iran University of Medical Sciences, Rashid Yasemi Street, Vanak Square
City
Tehran
Postal code
Phone
+98 21 8888 2886
Fax
Email
r.chekini@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)