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IRCT20221121056563N1 IRCT 2023-01-04 Oroumia University of Medical Sciences 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. 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. 2022-12-02 anticipated 94 Complete https://irct.ir/trial/66965 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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. 3 Condition 1: Polycystic ovarian syndrome. Condition 2: Vitamin D deficiency, unspecified. Intervention 1: Intervention group1: Probiotic group - Vitamin D 50,000 IU vitamin D3 every two weeks along with one capsule of Lactofem containing Lactobacillus rhamnosus, Lactobacillus fermentum, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus acidophilus, Lactobacillus gasseri and Lactobacillus bulgaricus in the amount of 109 CFU along with fructo-oligosaccharides as prebiotics. They will receive the prebiotic daily. Intervention 2: Intervention group 2:In the vitamin D group, they will receive 50,000 IU of vitamin D3 every 2 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Shaghayegh Torabali
Boostan dormitory، Zaker St، Apadana Crossroad، Urmia city، West Azarbaijan provience
Urmia Iran (Islamic Republic of) 5714783734 +98 21 3604 7297 13141375a@gmail.com Oroumia University of Medical Sciences scientific Shaghayegh Torabali
Boostan dormitory، Zaker St، Apadana Crossroad، Urmia city،West Azarbaijan provience
Urmia Iran (Islamic Republic of) 5714783734 +98 21 3604 7297 13141375a@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Age range 18-40 years A resident of Urmia Diagnosis of PCOS based on the Rotterdam indices. The Rotterdam criteria include having more than two of these symptoms: oligo/no ovulation, hyperandrogenism (symptoms such as hirsutism, acne, male pattern alopecia, increased free testosterone) and polycystic ovaries based on ultrasound (having 12 or more The follicle in each ovary is 2-9 mm in size People with blood levels of 25 hydroxyvitamin D less than 30 ng/ml 18 years 40 years Female Pregnancy or lactation, Endocrine glands problems: adrenal hyperplasia, androgen-secreting tumor, hyperprolactinemia, thyroid dysfunction, diabetes, Cushing's syndrome. History of premature menopause, smoking or history of smoking, significant changes in diet, and people who have taken antibiotics one month before the start of the study. Taking a probiotic supplement. Having any disorder other than PCOS that is associated with excessive androgens and menstrual irregularities, vitamin D sensitivity Having a chronic disease such as autoimmune disease, active liver disease, having a history of heart and kidney diseases, pancreatitis, lung disease and having a diet and any type of additional physical activity such as aerobics and using omega-3 and multivitamins Using drugs that interfere with vitamin D, such as anticonvulsants, rifampin and isoniazid, digoxin, and magnesium hydroxide and aluminum hydroxide antacids. alcohol consumption Allergy to probiotics E28.2 E55.9 Polycystic ovarian syndrome Vitamin D deficiency, unspecified Treatment - Other Treatment - Other Intervention group1: Probiotic group - Vitamin D 50,000 IU vitamin D3 every two weeks along with one capsule of Lactofem containing Lactobacillus rhamnosus, Lactobacillus fermentum, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus acidophilus, Lactobacillus gasseri and Lactobacillus bulgaricus in the amount of 109 CFU along with fructo-oligosaccharides as prebiotics. They will receive the prebiotic daily. Intervention group 2:In the vitamin D group, they will receive 50,000 IU of vitamin D3 every 2 weeks. Serum level of 25 hydroxyvitamin D. Timepoint: The beginning and end of the study. Method of measurement: blood sample. Weight. Timepoint: The beginning and end of the study. Method of measurement: Scale. Body composition. Timepoint: The beginning and end of the study. Method of measurement: Bioelectrical Impedance Analysis. Body Mass Index. Timepoint: The beginning and end of the study. Method of measurement: Bioelectrical Impedance Analysis. Oroumia University of Medical Sciences Approved 2022-10-29 Ethics committee of Urmia University of Medical Sciences Boostan dormitory، Zaker St، Apadana crossroad، Urmia city، West Azarbaijan Urmia West Azarbaijan Iran (Islamic Republic of)