The Effect of Calcium and Vitamin D Supplements on Metabolic and Hormonal Disturbances in Polycystic Ovary Syndrome Patients

• Status: Completed
• Trial end date: 2017-12-30
• Target enrollment: 0
• Participant gender: Female

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 compared to (placebo+ metformin).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Damascus University
• Treatments: Calcium; Calcium Carbonate; Calcium, Dietary; Cholecalciferol; Ergocalciferols; Metformin; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.