The effect of vitamin D supplementation on treatment, metabolic profiles and hs-CRP in women with cervical intraepithelial neoplasia 1(CIN1)

Objective: The aim of this study is to determine the effects of vitamin D supplementation on treatment, metabolic profiles and hs-CRP in women with cervical intraepithelial neoplasia 1(CIN1).

In this randomized double-blind placebo-controlled trial, patients will be assigned into two groups to receive vitamin D supplements or placebo.

58 women with cervical intraepithelial neoplasia 1 eligible and referred to Oncology Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.

Patients aged between 18 and 55 years with cervical intraepithelial neoplasia 1will 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 group: Vitamin D pearl, 50000 IU (Zahravi, Tabriz, Iran), every 2 weeks, for 6 months orally. Control group: Placebo pearl (Barij Essence, Kashan, Iran), every 2 weeks, for 6 months orally.

Fasting plasma glucose (FPG), serum levels of insulin, lipid profiles and hs-CRP.

Due to an error, the request for an update in our website has been conducted after paper published. However, the revisions were in accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.

Kashan University of Medical Sciences

At study baseline and after stratification for pre-intervention BMI and age, participants in each block will be randomly allocated into two treatment groups to take either vitamin D supplements (n = 29) or placebo (n = 29). Randomization will be done by the use of Stat Trek software. Participants, investigators or the assessors of the outcomes are also unaware of the study groups. https://stattrek.com/statistics/random-number-generator.aspx

Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Naghavi outpatient Clinic who is not involved in the trial and not aware of random sequences will allocate the numbered bottles of capsules to participants. Supplements and placebo are in the same packaging at the Barij Essence pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded.