Clinical trial of the effect of folate 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 folate 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: 60 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 folate supplements (intervention group: n=30) and placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 3-mo intervention. Start and end date of intervention: 3 months. Outcomes: Metabolic profiles will be meseaured at study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021417639N2
Registration date:2017-02-27, 1395/12/09
Registration timing:na
Last update:
Update count:0
Registration date
2017-02-27, 1395/12/09
Registrant information
Name
MOJGAN NOURIAN
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2671
Email address
nourian@hlth.mui.ac.ir
Recruitment status
Not enough for processing
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2017-01-22, 1395/11/03
Expected recruitment end date
2016-03-22, 1395/01/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of folate 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:
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
Ethics committee of Isfahan University of Medical Sciences
Street address
Building No. 4, Hezar Jerib Avenue, Isfahan University of Medical Science, Isfahan
City
Isfahan
Postal code
Approval date
2017-01-22, 1395/11/03
Ethics committee reference number
IR.MUI.REC.1395.3.733
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
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Colposcopy
Secondary outcomes
1
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
3
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
8
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
9
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
10
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention