Protocol summary
-
Study aim
-
Objective: The aim of this study is to determine the effects of vitamin D supplementation on recurrence and metabolic profiles in women with cervical intraepithelial neoplasia 2 and 3.
-
Design
-
In this randomized double-blind placebo-controlled trial, patients will be assigned into two groups to receive vitamin D supplements or placebo.
-
Settings and conduct
-
58 women with CIN2-3 eligible and referred to Oncology Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
-
Participants/Inclusion and exclusion criteria
-
Patients aged between 25 and 65 years with CIN2-3 will 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.
-
Intervention groups
-
Patients will be assigned to receive either 50000 IU vitamin D supplement every 2 weeks (intervention group: n=29) or placebo (control group: n=29).
-
Main outcome variables
-
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
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT201601045623N65
Registration date:
2016-01-04, 1394/10/14
Registration timing:
registered_while_recruiting
Last update:
2019-09-23, 1398/07/01
Update count:
1
-
Registration date
-
2016-01-04, 1394/10/14
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Vice chancellor for research, Kashan University of Medical Sciences
-
Expected recruitment start date
-
2015-12-22, 1394/10/01
-
Expected recruitment end date
-
2016-02-20, 1394/12/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Clinical trial of the effect of vitamin D supplementation compared with the placebo on recurrence and metabolic profiles in women with cervical intraepithelial neoplasia 2 and 3
-
Public title
-
Effect of supplementation in treatment of women with cervical intraepithelial neoplasia 2 and 3
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Women with cervical intraepithelial neoplasia 2 and 3
Aged 25 to 65 years old
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
-
Age
-
From 25 years old to 65 years old
-
Gender
-
Female
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
58
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
t study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either vitamin D supplements (n = 29) or placebo (n = 29). Randomization will be done by the use of computer-generated random numbers.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
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 Kashan 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.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
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 Kashan 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.
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2015-12-22, 1394/10/01
-
Ethics committee reference number
-
IR.Kaums.REC.1394.129
Health conditions studied
1
-
Description of health condition studied
-
Cervical intraepithelial neoplasia 2 and 3
-
ICD-10 code
-
C53.9
-
ICD-10 code description
-
Cervix uteri, unspecified
Primary outcomes
1
-
Description
-
Recurrence
-
Timepoint
-
Six months after intervention
-
Method of measurement
-
Colposcopy
Secondary outcomes
1
-
Description
-
Insulin
-
Timepoint
-
At the beginning of the study and after 6 months of intervention
-
Method of measurement
-
Elisa kit
2
-
Description
-
Nitric oxide
-
Timepoint
-
At the beginning of the study and after 6 months of intervention
-
Method of measurement
-
Spectrophotometry
3
-
Description
-
hs-CRP
-
Timepoint
-
At the beginning of the study and after 6 months of intervention
-
Method of measurement
-
Elisa kit
4
-
Description
-
Triglycerides
-
Timepoint
-
At the beginning of the study and after 6 months of intervention
-
Method of measurement
-
Enzymatic kit
5
-
Description
-
Cholesterol
-
Timepoint
-
At the beginning of the study and after 6 months of intervention
-
Method of measurement
-
Enzymatic kit
6
-
Description
-
Total antioxidant
-
Timepoint
-
At the beginning of the study and after 6 months of intervention
-
Method of measurement
-
Spectrophotometry
7
-
Description
-
Malondialdehyde
-
Timepoint
-
At the beginning of the study and after 6 months of intervention
-
Method of measurement
-
Spectrophotometry
8
-
Description
-
Fasting blood sugar
-
Timepoint
-
At the beginning of the study and after 6 months of intervention
-
Method of measurement
-
Baseline and End-of-trial
9
-
Description
-
Serum vitamin D
-
Timepoint
-
At the beginning of the study and after 6 months of intervention
-
Method of measurement
-
Elisa kit
10
-
Description
-
HDL
-
Timepoint
-
At the beginning of the study and after 6 months of intervention
-
Method of measurement
-
Enzymatic kit
11
-
Description
-
Insulin resistance
-
Timepoint
-
At the beginning of the study and after 6 months of intervention
-
Method of measurement
-
Calculation using HOMA formula
Intervention groups
1
-
Description
-
Intervention group: Vitamin D supplement, 50000 IU, every 2 weeks, for 6 months orally.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Placebo, every 2 weeks, for 6 months orally.
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Vice chancellor for research, Kashan University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available