A Randomized, Double‐Blind, Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Metabolic and Fertility Parameters in PCOS Women
Phase 4
18 Years
44 Years
18 Years
44 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome, Healthy, Vitamin D Deficiency
Female
Polycystic Ovary Syndrome, Healthy, Vitamin D Deficiency
Trial Information
A Randomized, Double‐Blind, Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Metabolic and Fertility Parameters in PCOS Women
Inclusion Criteria:
PCOS women:
- 25(OH)D levels below 30 ng/ml (measured at the baseline visit)
- Polycystic ovary syndrome defined by the Androgen Excess Society (AES) criteria
- Female, age of ≥ 18 and <45 years
- BMI status: 75 PCOS women with BMI ≤25 kg/m² and 75 PCOS women with BMI>25 kg/m²
- Written informed consent before study entry
Control women:
- 25(OH)D levels below 30 ng/ml (measured at the baseline visit)
- Female, age of ≥ 18 and <45 years
- BMI status: 75 nonPCOS women with BMI ≤25 kg/m² and 75 nonPCOS women with BMI>25
kg/m²
- Written informed consent before study entry
Exclusion Criteria:
PCOS women:
- Hypercalcemia defined as a serum calcium > 2,7 mmol/L
- Pregnancy or lactating women
- Disorders associated with androgen excess and/or menstrual irregularities apart from
PCOS (thyroid dysfunction, hyperprolactinemia, adrenal hyperplasia, androgen
secreting tumors)
- Prevalent type 2 diabetes
- Regular intake of vitD supplements at any time before study entry
- Intake of medication influencing metabolic or endocrine parameters (insulin
sensitizers, oral contraceptives, …) in the last 3 months before study entry
Control women:
- Hypercalcemia defined as a serum calcium > 2,7 mmol/L
- Established PCOS or any of the AES criteria 29 (hyperandrogenism (clinical and/or
biochemical), oligo- or anovulation, or polycystic ovaries on ultrasound)
- Disorders associated with androgen excess and/or menstrual irregularities apart from
PCOS (thyroid dysfunction, hyperprolactinemia, adrenal hyperplasia, androgen
secreting tumors)
- Prevalent type 2 diabetes
- Pregnancy or lactating women
- Regular intake of vitD supplements at any time before study entry
- Intake of medication influencing metabolic or endocrine parameters (insulin
sensitizers, oral contraceptives, …) in the last 3 months before study entry
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCgluc
Outcome Time Frame:
Change from Baseline in AUC gluc at 24 weeks
Safety Issue:
No
Principal Investigator
Elisabeth Lerchbaum, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical University of Graz
Authority:
Austria: Federal Office for Safety in Health Care
Study ID:
VitDPCOS1.0
NCT ID:
NCT01721915
Start Date:
October 2012
Completion Date:
December 2015
Related Keywords:
- Polycystic Ovary Syndrome
- Healthy
- Vitamin D Deficiency
- Polycystic Ovary Syndrome (PCOS)
- glucose metabolism
- Vitamin D deficiency
- vitamin D supplementation
- pharmakogenetics
- women
- Polycystic Ovary Syndrome
- Vitamin D Deficiency
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