Comparision of the effect of vitamin D3 and probiotic containing lactic acid bacteria co-supplementation with vitamin D3 on serum 25(OH)D levels in patients with polycystic ovary syndrome.

Determining the simultaneous effect of vitamin D supplementation and probiotics containing lactic acid bacteria compared to vitamin D supplementation on serum 25(OH) D levels in patients with polycystic ovary syndrome

A randomized, parallel-group clinical trial, phase 3, on 94 patients. People were equally divided into two groups based on the table of random numbers. The first group of this study is the probiotic-vitamin D group, and the second group is the vitamin D group. This study was not blinded.

Study setting: Imam Khomeini Medical Education Center in Urmia. P. Probiotic supplement in the form of lactofem capsules will be provided from Zist takhmir Company, and vitamin D3 supplement will be provided in the form of vitamin D3 gelatin capsules with a dose of 50,000 from Dana Pharmaceutical Company. The intervention period in this trial is 12 weeks. A blood sample of 2 ml will be taken from the participants in the study at the beginning and at the end of the study on a specific day by a laboratory science expert of the center, and the serum level of 25 hydroxyvitamin D will be measured by ELISA method. will be taken. People are asked to visit the nutrition clinic every two weeks and receive their next supplement package.

Patients with polycystic ovary syndrome who have referred to Imam Khomeini Medical Education Center to diagnose their disease.

The probiotic-vitamin D group will receive 50,000 IU of vitamin D3 every two weeks along with one Lactofem capsule daily. In the vitamin D group, they will receive 50,000 IU of vitamin D3 every 2 weeks.

Serum level of 25(OH)D

Randomization is done in the form of a table of random numbers. A table of random numbers is a collection of numbers that are generated completely randomly without a specific pattern or order and are made into a table. In order to use the table of random numbers, first the direction of reading the numbers in the table is predetermined (for example, up, down, left or right), the second assumption is to consider numbers for different groups (for example, even numbers for vitamin D group) and odd numbers for the probiotic-vitamin D group). In fact, the patients referred to the endocrinology clinic of Imam Khomeini (RA) Urmia Medical Education Center are selected by the endocrinology subspecialist based on the entry and exit criteria. Each selected patient goes to the researcher, then the researcher puts his hand on one of the numbers and moves in one of the predetermined directions and records the number. If the number is even, the patient is placed in the vitamin D group, and if the patient's odd number was placed in the probiotic-vitamin D group. Patients enter the study in order and receive the code related to the desired group according to the method explained.