Status:
COMPLETED
The Effect of Calcium and Vitamin D Supplements on Metabolic and Hormonal Disturbances in Polycystic Ovary Syndrome Patients
Lead Sponsor:
Damascus University
Conditions:
Polycystic Ovary Syndrome
Vitamin D Deficiency/Insufficiency
Eligibility:
FEMALE
18-30 years
Phase:
PHASE3
Brief Summary
The aim of this study is to investigate the safety and metabolic-hormonal efficiency of supplementation vitamin D deficient/insufficient PCOS women with (calcium +vitamin D + metformin) for 8 weeks co...
Detailed Description
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder among females of reproductive age. The main manifestations of this syndrome are ovulatory dysfunction, hyperandrogenism, and poly...
Eligibility Criteria
Inclusion
- PCOS women aged 18-30 years diagnosed according to the Rotterdam criteria.
- Vitamin D deficiency or insufficiency according to the Endocrine Society Clinical Practice Guideline.
- Normal liver function.
- Normal kidney function.
Exclusion
- Pregnant, postpartum or breastfeeding women.
- Females aged \<18 or \>30 years old.
- Patients who were diagnosed with androgen-secreting tumours, Cushing's syndrome, congenital adrenal hyperplasia, hyperprolactinemia, hypercalcemia, malabsorption disorders, diabetes mellitus, thyroid disorders, liver disease, renal disease, epilepsy, cardiovascular disease.
- History of kidney stones.
- Usage of any hormonal therapy, corticosteroids (other than topical corticosteroids forms), insulin sensitizers, hypolipidemic agents, anti-obesity medications, vitamin D or calcium supplements, anti-epileptic drugs, or any other drugs known to affect endocrine parameters, carbohydrate metabolism, or calciotropic hormone concentrations during the last 3 months.
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03792984
Start Date
December 1 2016
End Date
December 30 2017
Last Update
June 6 2019
Active Locations (2)
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1
Damascus University of Obstetrics and Gynecology Hospital
Damascus, Syria
2
Orient Hospital
Damascus, Syria