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NCT Number: NCT01721915

Vitamin D Treatment, Pharmacogenetics and Glucose Metabolism

Background: Polycystic ovary syndrome (PCOS) is as common as 5-10% of all women in Austria. PCOS women frequently present with metabolic disturbances, hyperandrogenism and infertility. New therapy concepts are warranted. In our recent pilot study, vitamin D (vitD) supplementation significantly improved glucose metabolism and fertility. However, the efficacy of vitD administration shows individual variability indicating endogenous influences on pharmacological effects.

A recent genome-wide association study reported three loci (DHCR7, CYP2R1, and GC) associated with vitD insufficiency. Moreover, vitD receptor (VDR) gene variants have already been known to be associated with insulin resistance.

Aim: To test the hypothesis that vitD is efficient in changing metabolic parameters in PCOS and non-PCOS women longitudinally and to generate data on pharmacogenetic effects of vitD related genetic determinants adjusted for environmental factors.

Primary outcome: Change from baseline in AUCgluc after vitD treatment. Secondary outcome: To generate the hypothesis that changes in metabolic and endocrine parameters following vitD treatment are associated with vitD related gene variants.

Methods: 150 PCOS women with 25-hydroxyvitamin D (cholecalciferol, [25(OH)D]) levels <30 ng/ml will be treated with vitD (20,000 IU/wk) or placebo in a 2:1 randomized controlled trial over 24 weeks and investigated for metabolic and endocrine parameters as well as vitD related genetic variants. In addition, 150 non-PCOS women with 25(OH)D <30 ng/ml will be treated with vitD (20,000 IU/wk) or placebo in a 2:1 randomized controlled trial over 24 weeks and investigated for metabolic and endocrine parameters as well as vitD related genetic variants. The response to vitD supplementation in both groups will be analysed according to genotype profiles.

Significance: VitD might be a new therapeutic option without major side effects for PCOS patients. Exploring specific loci for pharmacogenetic vitD actions would open a new window for therapy modulation in PCOS and other metabolic diseases.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Avitaminosis Cysts Deficiency Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Healthy Malnutrition Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Urogenital Diseases Vitamin D Deficiency

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism

Graz, 8036, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D supplementation

Drug

The treatment group will receive an oral dose of 20,000 IU vitD weekly (equivalent to 2857 IU/day) as oily drops (Oleovit D3-drops; producer: Fresenius Kabi Austria GmbH, Linz)

Other names: A11CC05 Colecalciferol

Placebo

Drug

Primary outcomes

  1. Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCgluc

    Time frame: Change from Baseline in AUC gluc at 24 weeks

Secondary outcomes

  1. Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)

    Time frame: Change from Baseline in insulin resistance at 24 weeks

  2. Lipid levels (total cholesterol)

    Time frame: Change from Baseline in total cholesterol at 24 weeks

  3. HbA1c

    Time frame: Change from Baseline in HbA1c at 24 weeks

  4. Testosterone

    Time frame: Change from Baseline in testosterone at 24 weeks

  5. Menstrual frequency

    Time frame: Change from Baseline in menstrual frequency at 24 weeks

  6. Insulin sensitivity assessed by Quantitative Insulin-sensitivity Check Index (QUICKI)

    Time frame: Change from baseline in QUICKI at 24 weeks

  7. Free testosterone (FT)

    Time frame: Change from Baseline in FT at 4 weeks

  8. Triglycerides

    Time frame: Change from Baseline in triglycerides at 24 weeks

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • Austrian Science Fund (FWF)

Registry information

Official study title

A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Metabolic and Fertility Parameters in PCOS Women

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Nov 6, 2012
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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