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
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. Study design: Parallel double-blind (both participants and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Women with cervical intraepithelial neoplasia 2 and 3, and aged 18 to 55 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 58 patients with cervical intraepithelial neoplasia 2 and 3 of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Participants will be assigned to receive either vitamin D supplements (intervention group: n=29) and placebo (control group: n=29). Fasting blood samples will be taken at baseline and after 6-mo intervention. Start and end date of intervention: 6 months. Outcomes: Metabolic profiles will be meseaured at study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601045623N65
Registration date:2016-01-04, 1394/10/14
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-01-04, 1394/10/14
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
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 18 to 55 years old.
Exclusion criterion: unwillingness to cooperate.
Age
From 18 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
58
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
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
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
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
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
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
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)