Protocol summary
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Study aim
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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)
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Design
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In this randomized double-blind placebo-controlled trial, patients will be assigned into two groups to receive selenium supplements or placebo.
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Settings and conduct
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56 women with CIN1 eligible and referred to Kossar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Patients aged between 18 and 55 years with CIN1will be included. The exclusion criteria will be as follows: women who had a history of cervical cancer or other cancers of the lower genital tract, a history of hysterectomy or destructive therapy of the cervix and pregnant women.
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Intervention groups
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Patients will be assigned to receive either 200 µg selenium supplement (intervention group: n=28) or placebo (control group: n=28).
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Main outcome variables
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Fasting blood samples will be taken at baseline and after 6 months of intervention to measure metabolic profiles. Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin, lipid profiles and hs-CRP levels.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201412215623N32
Registration date:
2015-01-06, 1393/10/16
Registration timing:
retrospective
Last update:
2019-09-11, 1398/06/20
Update count:
1
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Registration date
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2015-01-06, 1393/10/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Arak University of Medical Sciences
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Expected recruitment start date
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2014-03-18, 1392/12/27
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Expected recruitment end date
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2014-08-10, 1393/05/19
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of selenium supplementation on regression and metabolic profiles in women with cervical intraepithelial neoplasia 1(CIN1)
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Public title
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Effect of supplementation in regression of cervical intraepithelial neoplasia 1
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women aged 18-55 years; diagnosed with cervical intraepithelial neoplasia 1
Exclusion criteria:
Women who had a history of cervical cancer or other cancers of the lower genital tract
History of hysterectomy or destructive therapy of the cervix
Pregnant women
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Age
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From 18 years old to 55 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
56
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either selenium supplements (n = 28) or placebo (n = 28). Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Oncology Clinic at the Arak University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2014-03-17, 1392/12/26
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Ethics committee reference number
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92-160-6
Health conditions studied
1
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Description of health condition studied
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Cervical intraepithelial neoplasia 1(CIN1)
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ICD-10 code
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C53
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ICD-10 code description
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Malignant neoplasm of cervix uteri
Primary outcomes
1
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Description
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Cervical intraepithelial neoplasia grade 1
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Colposcopy
Secondary outcomes
1
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Description
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Insulin
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa kit
2
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Description
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Insulin resistance
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Calculation using HOMA formula
3
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Description
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Total cholesterol
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic kit
4
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Description
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Triglycerides
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic kit
5
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Description
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HDL
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic kit
6
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Description
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High-sensitivity C-reactive Protein
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa kit
7
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Description
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Nitric oxide
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
8
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Description
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Glutathione
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
9
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Description
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Total antioxidant capacity
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
10
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Description
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Malondialdehyde
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
11
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Description
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Fasting blood sugar
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic kit
Intervention groups
1
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Description
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Control group: Placebo tablet, daily, for 6 months orally.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Selenium tablet, 200 µg, daily, for 6 months orally.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Arak University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available