Objective: The aim of this study is to determine the effects of folic acid supplementation on treatment, metabolic profiles and hs-CRP 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 Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either 5 mg folic acid 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 and inflammatory factor. Start and End Date of Intervention: 6 months (March 1, 2014-September 1, 2014). 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:IRCT201403155623N17
Registration date:2014-03-25, 1393/01/05
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2014-03-25, 1393/01/05
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
Kashan University of Medical Sciences
Expected recruitment start date
2014-02-27, 1392/12/08
Expected recruitment end date
2014-07-30, 1393/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of folate supplementation on treatment, metabolic profiles and hs-CRP in women with cervical intraepithelial neoplasia 1(CIN1)
Public title
Effect of supplementation in treatment 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.