| May 3, 2017 |
summary |
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=30) and placebo (control group: n=30). 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.
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