The effects of vitamin D supplementation on hormonal profiles, inflammatory factors, oxidative stress biomarkers and gene expression related to inflammation in women with polycystic ovary syndrome candidates for IVF

Objective: The aim of this study is to determine the effects of vitamin D supplementation on hormonal profiles, inflammatory factors, oxidative stress biomarkers and gene expression related to inflammation in patients with polycystic ovary syndrome candidates for IVF

Study design: Randomized double-blind placebo-controlled trial, All participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two groups. Randomization will be done by the use of computer software.

Among patients with polycystic ovary syndrome candidates for IVF referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 40 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 8 weeks after the intervention. At the beginning and the end of the intervention: 8 weeks

Inclusion criteria: Patients with polycystic ovary syndrome candidates for IVF aged 18 to 40 years. Exclusion criteria: Individuals with neoplastic disorders, cardiovascular diseases, malabsorptive disorders, and current or previous (within the last 6 months) use of hormonal; antidiabetic and anti-obesity medications.

Intervention group: 50000 IU vitamin D3 (Zahravi, Tabriz, Iran), weekly, for 8 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), weekly, for 8 weeks orally.

Outcomes: Total testosterone (primary outcome) and biomarkers of inflammation, oxidative stress and gene expression related to inflammation (secondary outcomes) will be quantified at study baseline and end-of-trial

To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.

Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Kosar clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules