Polycystic Ovary SyndromePhase 4NCT01721915
Vitamin D Treatment, Pharmacogenetics and Glucose Metabolism
A Phase 4 study testing Vitamin D supplementation in people with Polycystic Ovary Syndrome and Healthy, run by Medical University of Graz at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Healthy, Vitamin D Deficiency
- What is being tested?
- Vitamin D supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2012to 12 Oct 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism
Graz, 8036
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Metabolic and Fertility Parameters in PCOS Women
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.
Read more
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.
- Conditions
- Polycystic Ovary Syndrome, Healthy, Vitamin D Deficiency
- Being tested
- Vitamin D supplementation, Placebo
- Keywords
- Polycystic Ovary Syndrome (PCOS), glucose metabolism, Vitamin D deficiency, vitamin D supplementation, pharmakogenetics, women
- Medical subject headings
- Polycystic Ovary Syndrome, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D supplementationDrug
Also called A11CC05 Colecalciferol
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)
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D supplementation | Experimental | 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) Receives: Drug: Vitamin D supplementation |
| Placebo | Placebo comparator | the placebo group will receive oily drops without vitD Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCgluc
Measured: Change from Baseline in AUC gluc at 24 weeks
Secondary outcomes (8)
Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)
Measured: Change from Baseline in insulin resistance at 24 weeks
Lipid levels (total cholesterol)
Measured: Change from Baseline in total cholesterol at 24 weeks
HbA1c
Measured: Change from Baseline in HbA1c at 24 weeks
Testosterone
Measured: Change from Baseline in testosterone at 24 weeks
Menstrual frequency
Measured: Change from Baseline in menstrual frequency at 24 weeks
Insulin sensitivity assessed by Quantitative Insulin-sensitivity Check Index (QUICKI)
Measured: Change from baseline in QUICKI at 24 weeks
Free testosterone (FT)
Measured: Change from Baseline in FT at 4 weeks
Triglycerides
Measured: Change from Baseline in triglycerides at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startOct 2012
- Primary completion12 Oct 2017
- Study completion12 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Austrian Science Fund (FWF)
- Responsible party
- Principal investigator, Lerchbaum Elisabeth, MD, Medical University of Graz
- Investigators
- Elisabeth Lerchbaum, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721915
- Sponsor's protocol ID
- VitDPCOS1.0
- Other IDs
- KLI 274
- Status last verified
- Mar 2018
- First submitted
- 31 Oct 2012
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Metabolic and Fertility Parameters in PCOS Women
- ClinicalTrials.gov ID
- NCT01721915
- Acronym / sponsor ID
- VitDPCOS1.0
- Conditions
- Polycystic Ovary Syndrome, Healthy, Vitamin D Deficiency
- Keywords
- Polycystic Ovary Syndrome (PCOS), glucose metabolism, Vitamin D deficiency, vitamin D supplementation, pharmakogenetics, women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Austrian Science Fund (FWF)
- Study start
- Oct 2012 (actual)
- Primary completion
- 12 Oct 2017 (actual)
- Study completion
- 12 Oct 2017 (actual)
- First posted
- 6 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D supplementation | Experimental | Drug: Vitamin D supplementationThe 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) |
| Placebo | Placebo comparator | Drug: Placebothe placebo group will receive oily drops without vitD |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D supplementationAlso: A11CC05 ColecalciferolThe 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) | Drug | Vitamin D supplementation |
| Placebo | Drug | Placebo |
Primary outcome
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCgluc
Time frame: Change from Baseline in AUC gluc at 24 weeks
8 secondary outcomes
Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR)
Time frame: Change from Baseline in insulin resistance at 24 weeks
Lipid levels (total cholesterol)
Time frame: Change from Baseline in total cholesterol at 24 weeks
HbA1c
Time frame: Change from Baseline in HbA1c at 24 weeks
Testosterone
Time frame: Change from Baseline in testosterone at 24 weeks
Menstrual frequency
Time frame: Change from Baseline in menstrual frequency at 24 weeks
Insulin sensitivity assessed by Quantitative Insulin-sensitivity Check Index (QUICKI)
Time frame: Change from baseline in QUICKI at 24 weeks
Free testosterone (FT)
Time frame: Change from Baseline in FT at 4 weeks
Triglycerides
Time frame: Change from Baseline in triglycerides at 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Lerchbaum, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D supplementation in people with Polycystic Ovary Syndrome and Healthy, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCgluc (time frame: Change from Baseline in AUC gluc at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.