Objective: The aim of this study is to determine the effects of selenium supplementation on regression and metabolic profiles in women with cervical intraepithelial neoplasia 1(CIN1). Study design: parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Women aged 18-55 years diagnosed with CIN1 will be included in this study. Individuals with neoplastic, cardiovascular disorders, malabsorptive disorders, current or previous (within the last 6 months) use of hormonal, antidiabetic medications and anti-obesity medications will be excluded in the study. Population and sample size: 60 women with CIN1 eligible and referred to Kossar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either 200 µg selenium supplement (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 6 months of intervention to measure metabolic profiles. Start and End Date of Intervention: 6 months (August 23, 2014-Februrary 23, 2015). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin, lipid profiles and hs-CRP levels.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412215623N32
Registration date:2015-01-06, 1393/10/16
Registration timing:retrospective
Last update:
Update count:1
Registration date
2015-01-06, 1393/10/16
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of selenium supplementation on regression and metabolic profiles in women with cervical intraepithelial neoplasia 1(CIN1)
Public title
Effect of supplementation in regression of cervical intraepithelial neoplasia 1
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Women aged 18-55 years; diagnosed with cervical intraepithelial neoplasia 1.
Exclusion Criteria: Individuals with neoplastic; cardiovascular disorders; malabsorptive disorders; current or previous (within the last 6 months) use of hormonal; antidiabetic medications; anti-obesity medications.
Age
From 18 years old to 55 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
Arak University of Medical Sciences
Street address
Vice-chancellor for Education and Research, Sardasht Avenue, Arak
City
Arak
Postal code
Approval date
2014-03-17, 1392/12/26
Ethics committee reference number
92-160-6
Health conditions studied
1
Description of health condition studied
Cervical intraepithelial neoplasia 1(CIN1)
ICD-10 code
C53
ICD-10 code description
Malignant neoplasm of cervix uteri
Primary outcomes
1
Description
Fasting plasma glucose
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
2
Description
Triglycerides
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
3
Description
Cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
4
Description
Glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
5
Description
Total antioxidant capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
6
Description
Malondialdehyde
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
7
Description
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Placebo tablet, daily, for 6 months orally.