Polycystic Ovary SyndromePhase 2NCT04840238
30000 IU Per Week Vitamin D Treatment in PCOS Patients
A Phase 2 study testing Cholecalciferol in people with Polycystic Ovary Syndrome and Vitamin D Deficiency, run by Semmelweis University at 8 sites in Hungary.
Trial summary
This is a human, II/b phase, multicentre, randomised, double blind, placebo-controlled study to assess the safety and the efficacy of a weekly administered dose of 30,000 IU vitamin D (colecalciferol) in deficient patients diagnosed with PCOS. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Vitamin D Deficiency
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 8 sitesHungary
- Study dates
- 8 Dec 2016to Dec 2022
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subject age >18 years.
- Clinical and/or biochemical hyperandrogenism and the proven PCOS by the "Rotterdam" criteria, (ovarian dysfunction, oligo- and/or anovulation, and the morphology of polycystic ovaries on ultrasound images when other etiologies are excluded)
- 25(OH)D levels are between 10-28 ng/ml by inclusion
- Subject can not be under any kind of ongoing hormone or metformin therapies and no indication that requires continuation
- Has the ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study or initiation of study procedures
- Study subject has the ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study or initiation of study procedures
Who cannot join
- Has been exposed to any investigational agent within 3 month of enrolment to the study
- Sever metabolic disease on endocrine disease in etiology different from PCOS
- Significant obesity (BMI> 36)
- Any other signs of lab results that may lead to other etiologies in differentiation, or menopause
- Increased serum calcium level results or symptoms of hypercalcemia in last one year
- Hypercalciuria or kidney stone appearance in last one year
Show all 26Show fewer
- Sever kidney diseases (CKD 3 or higher)
- Chronic or serious disease, which can significantly influence the absorption, metabolism of vitamin D or Ca
- Heart failure or angina pectoris,
- More than 1000 IU vitamin D per day intake or in total >5000 IU per week within 1 month prior to trial (in any forms medication, or nutritional food supplement). The patient is not under hormonal therapy for ovulation stimulation purposes and was not involved in two months prior the study
- The patient is under hormonal therapy for the aim of ovulation stimulation or was involved in within 3 months prior the study
- Existence or suspected gravidity
- Any other finding or symptoms which are by the opinion of the Investigator may indicate a potential interference with the safety of participating trial subjects
- Has a known hypersensitivity to any of the investigational drug or vehicle components.
- Concomitant medication which is not allowed:
- glycosides
- metformin
- magnesium-containing preparations (antacids)
- cholestyramine and other ion exchange resins, orlistat
- thiazide diuretics
- regular use of microsomal enzyme inducers (anticonvulsants, sedatives, etc.).
- corticosteroids (except for dermatological use)
- products containing phosphorus
- regular use of laxatives (such as paraffin oil)
- fat absorption inhibitory drugs
- any kind of hormone therapy (including therapeutic use of birth control pills, within 2 months prior inclusion) except treatment of stabile hypothyroidism
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Hungary8 sites
Semmelweis University - Departement Medicine and Oncology
Budapest, 1083
MediMOM Healthy Center
Budapest, 1112
Róbert Károly Hospital
Budapest, 1136
Gynpraxis Nőgyógyászat
Debrecen, 4032
Somogy County Kaposi Mór Teaching Hospital
Kaposvár, 7400
Borsod-Abaúj-Zemplén County Hospital
Miskolc, 3526
SZTE-ÁOK - 1st Dept. of Internal MEdicine
Szeged, 6720
Gynofarm Outpatient Clinic
Székesfehérvár, 8600
About this study
Official title: A Multicentre, Phase-II, Randomised, Double Blind, Placebo-controlled Study to Assess the Safety and the Efficacy of a Weekly Administered Dose of 30,000 IU Vitamin D (Colecalciferol) in Deficient Patients Diagnosed With PCOS
This is a human, II/b phase, multicentre, randomised, double blind, placebo-controlled study to assess the safety and the efficacy of a weekly administered dose of 30,000 IU vitamin D (colecalciferol) in deficient patients diagnosed with PCOS.
Investigational products: 30.000 IU vitamin D or placebo administered once a week for 12-weeks-long period, followed by a 12-week-long open label treatment 30.000 IU vitamin D in a follow-up period.
Read more
Each participant should be checked for regular dietary Ca intake and to assure the optimal calcium level the supplementation is provided with a commercially available Citrocalcium 200 mg tablets.
Setting:
- Baseline and screening period:
Baseline period considered as when the exogenous Vitamin D intake should not exceed the level of 1000 IU intake per day or a total 5000 NE per week dosages applied (in forms of any Vitamin D3 medication or multivitamin products) at least for 30 days prior the assessment made.
II. Double-blind treatment period:
Once a week per os applied Vitamin D or placebo treatment for 12 weeks according to randomisation of trial subjects in a 1:1 assignment. By the end of this period an interim assessment will be performed based on the analysis of primary efficacy parameters, stratification to responder and non-responder groups.
III. Open label and follow-up phase:
An open-label 30000 IU of Vitamin D treatment on weekly basis. (Vitamin D3 Pharma Patent 30000 IU tablets) for additional 12 weeks and continue with the follow-up assessments. A compassionate use of patient diary for additional 26 weeks.
Objectives:
Primary objectives: to assess the efficacy as a recovery of ovarian function based on progesterone levels and menses diary in at least 20% of trial subjects, compared to placebo treated group Secondary Objectives: assess the efficacy and safety of orally administered vitamin D treatment by the changes in 25(OH) D levels in PCOS patients.
Explore the changes in Ovarian-morphology based on the results of standard TVUS Imaging: detection of adverse drug reactions during treatment periods, by frequency and distribution compared to follow-up periods and placebo group.
Anticipated participants: 168
- Conditions
- Polycystic Ovary Syndrome, Vitamin D Deficiency
- Being tested
- Cholecalciferol, Placebo
- 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.
CholecalciferolDrug
30,000IU cholecalciferol
PlaceboDrug
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol | Experimental | Cholecalciferol 30,000IU weekly orally Receives: Drug: Cholecalciferol |
| Placebo | Placebo comparator | Placebo tablets weekly orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of ovarian function
Recovery of ovarian function is detected by changes in progesterone levels (lutal phase progesterone level reaches 2 ng/ml)
Measured: Up to 32 weeks, continuously
Secondary outcomes (9)
Length of menstrual cycle
Determined by patient reported number of days between two menstrual cycles
Measured: Up to 32 weeks
Variation in menstrual cycles length
Determined by patient reported menstrual cycle length and regularity, measured in days
Measured: Up to 32 weeks
Incidence of adverse events
Incidence of adverse events (safety and tolerability), evaluated at every visit
Measured: Up to 32 weeks, continuously
Change in serum calcium level
Change in serum calcium levels in mmol/l (safety measure), evaluated every clinical visit
Measured: Up to 32 weeks, continuously
Change in urinary calcium/creatinine ratio
Change in urinary calcium/creatinine ratio ([mmol/l]/[umol/l]) (safety measure), evaluated every clinical visit
Measured: Up to 32 weeks
25(OH)D levels
Evaluation of treatment of changes in 25(OH)D blood levels compared between treatment groups
Measured: Up to 32 weeks
Change in fasting glucose level
Change in fasting glucose level (mmol/l), measured at every visit
Measured: Up to 32 weeks
Change in hemoglobin A1c level
Change in hemoglobin A1c level (IFCC validated, mmol/mol), measured every 12 weeks
Measured: Up to 32 weeks
Change in ovarian morphology
Changes in ovarian follicle count assessed by TVUS and evaluated by the Rotterdam criteria (having 12 or more follicles, measuring between 2 and 9 mm)
Measured: Up to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start8 Dec 2016
- Primary completionFeb 2022
- Study completionDec 2022
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 Semmelweis UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- Pharma Patent Kft.
- Responsible party
- Principal investigator, Istvan Takacs, Semmelweis University
- Investigators
- István Takács, MD, DSc., Principal investigator, Semmelweis University - Dept. of Medicine and Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840238
- Sponsor's protocol ID
- PAT15-PCODD
- Status last verified
- Jun 2024
- First submitted
- 14 Jul 2020
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Phase-II, Randomised, Double Blind, Placebo-controlled Study to Assess the Safety and the Efficacy of a Weekly Administered Dose of 30,000 IU Vitamin D (Colecalciferol) in Deficient Patients Diagnosed With PCOS
- ClinicalTrials.gov ID
- NCT04840238
- Acronym / sponsor ID
- PAT15-PCODD
- Conditions
- Polycystic Ovary Syndrome, Vitamin D Deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Collaborators
- Pharma Patent Kft.
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- Feb 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 9 Apr 2021 (actual)
- 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.
This is a human, II/b phase, multicentre, randomised, double blind, placebo-controlled study to assess the safety and the efficacy of a weekly administered dose of 30,000 IU vitamin D (colecalciferol) in deficient patients diagnosed with PCOS.
Investigational products: 30.000 IU vitamin D or placebo administered once a week for 12-weeks-long period, followed by a 12-week-long open label treatment 30.000 IU vitamin D in a follow-up period.
Each participant should be checked for regular dietary Ca intake and to assure the optimal calcium level the supplementation is provided with a commercially available Citrocalcium 200 mg tablets.
Setting:
- Baseline and screening period:
Baseline period considered as when the exogenous Vitamin D intake should not exceed the level of 1000 IU intake per day or a total 5000 NE per week dosages applied (in forms of any Vitamin D3 medication or multivitamin products) at least for 30 days prior the assessment made.
II. Double-blind treatment period:
Once a week per os applied Vitamin D or placebo treatment for 12 weeks according to randomisation of trial subjects in a 1:1 assignment. By the end of this period an interim assessment will be performed based on the analysis of primary efficacy parameters, stratification to responder and non-responder groups.
III. Open label and follow-up phase:
An open-label 30000 IU of Vitamin D treatment on weekly basis. (Vitamin D3 Pharma Patent 30000 IU tablets) for additional 12 weeks and continue with the follow-up assessments. A compassionate use of patient diary for additional 26 weeks.
Objectives:
Primary objectives: to assess the efficacy as a recovery of ovarian function based on progesterone levels and menses diary in at least 20% of trial subjects, compared to placebo treated group Secondary Objectives: assess the efficacy and safety of orally administered vitamin D treatment by the changes in 25(OH) D levels in PCOS patients.
Explore the changes in Ovarian-morphology based on the results of standard TVUS Imaging: detection of adverse drug reactions during treatment periods, by frequency and distribution compared to follow-up periods and placebo group.
Anticipated participants: 168
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 |
|---|---|---|
| Cholecalciferol | Experimental | Drug: CholecalciferolCholecalciferol 30,000IU weekly orally |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets weekly orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female subject age >18 years.
- Clinical and/or biochemical hyperandrogenism and the proven PCOS by the "Rotterdam" criteria, (ovarian dysfunction, oligo- and/or anovulation, and the morphology of polycystic ovaries on ultrasound images when other etiologies are excluded)
- 25(OH)D levels are between 10-28 ng/ml by inclusion
- Subject can not be under any kind of ongoing hormone or metformin therapies and no indication that requires continuation
- Has the ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study or initiation of study procedures
Key exclusion criteria (26 listed)
- Has been exposed to any investigational agent within 3 month of enrolment to the study
- Sever metabolic disease on endocrine disease in etiology different from PCOS
- Significant obesity (BMI> 36)
- Any other signs of lab results that may lead to other etiologies in differentiation, or menopause
- Increased serum calcium level results or symptoms of hypercalcemia in last one year
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 |
|---|---|---|
| Cholecalciferol30,000IU cholecalciferol | Drug | Cholecalciferol |
| PlaceboPlacebo tablets | Drug | Placebo |
Primary outcome
Recovery of ovarian function
Time frame: Up to 32 weeks, continuously
Recovery of ovarian function is detected by changes in progesterone levels (lutal phase progesterone level reaches 2 ng/ml)
9 secondary outcomes
Length of menstrual cycle
Time frame: Up to 32 weeks
Variation in menstrual cycles length
Time frame: Up to 32 weeks
Incidence of adverse events
Time frame: Up to 32 weeks, continuously
Change in serum calcium level
Time frame: Up to 32 weeks, continuously
Change in urinary calcium/creatinine ratio
Time frame: Up to 32 weeks
25(OH)D levels
Time frame: Up to 32 weeks
Change in fasting glucose level
Time frame: Up to 32 weeks
Change in hemoglobin A1c level
Time frame: Up to 32 weeks
Change in ovarian morphology
Time frame: Up to 32 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 24 Jun 2024.
- Individual participant dataSharing planned: No
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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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.
István Takács, MD, DSc. principal investigator
Semmelweis University - Dept. of Medicine and Oncology
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cholecalciferol in people with Polycystic Ovary Syndrome and Vitamin D Deficiency, run by Semmelweis University at 8 sites in Hungary.
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 6 inclusion and 26 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 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Hungary. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Recovery of ovarian function (time frame: Up to 32 weeks, continuously). 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 24 Jun 2024.