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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.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221121056563N1
Enrollment
94
Registered
2023-01-04
Start date
2022-12-02
Completion date
Unknown
Last updated
2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Polycystic ovarian syndrome. Condition 2: Vitamin D deficiency, unspecified. Polycystic ovarian syndrome Vitamin D deficiency, unspecified

Interventions

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, La

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Serum level of 25 hydroxyvitamin D. Timepoint: The beginning and end of the study. Method of measurement: blood sample.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShaghayegh Torabali

Oroumia University of Medical Sciences

13141375a@gmail.com+98 21 3604 7297

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026