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30000 IU Per Week Vitamin D Treatment in PCOS Patients

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ClinicalTrials.gov Identifier: NCT04840238
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : April 19, 2021
Sponsor:
Collaborator:
Pharma Patent Kft.
Information provided by (Responsible Party):
Istvan Takacs, Semmelweis University

Brief 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.

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:

I. 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


Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Vitamin D Deficiency Drug: Cholecalciferol Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 8, 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: Cholecalciferol
Cholecalciferol 30,000IU weekly orally
Drug: Cholecalciferol
30,000IU cholecalciferol

Placebo Comparator: Placebo
Placebo tablets weekly orally
Drug: Placebo
Placebo tablets




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Length of menstrual cycle [ Time Frame: Up to 32 weeks ]
    Determined by patient reported number of days between two menstrual cycles

  2. Variation in menstrual cycles length [ Time Frame: Up to 32 weeks ]
    Determined by patient reported menstrual cycle length and regularity, measured in days

  3. Incidence of adverse events [ Time Frame: Up to 32 weeks, continuously ]
    Incidence of adverse events (safety and tolerability), evaluated at every visit

  4. Change in serum calcium level [ Time Frame: Up to 32 weeks, continuously ]
    Change in serum calcium levels in mmol/l (safety measure), evaluated every clinical visit

  5. Change in urinary calcium/creatinine ratio [ Time Frame: Up to 32 weeks ]
    Change in urinary calcium/creatinine ratio ([mmol/l]/[umol/l]) (safety measure), evaluated every clinical visit

  6. 25(OH)D levels [ Time Frame: Up to 32 weeks ]
    Evaluation of treatment of changes in 25(OH)D blood levels compared between treatment groups

  7. Change in fasting glucose level [ Time Frame: Up to 32 weeks ]
    Change in fasting glucose level (mmol/l), measured at every visit

  8. Change in hemoglobin A1c level [ Time Frame: Up to 32 weeks ]
    Change in hemoglobin A1c level (IFCC validated, mmol/mol), measured every 12 weeks

  9. Change in ovarian morphology [ Time Frame: Up to 32 weeks ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Polycystic ovarian syndrome develops in only females
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04840238


Contacts
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Contact: Pál Szamosújvári, MD +36 1 630 61 82 clinical@pharmapatent.hu
Contact: István Takács, MD, DSc. +36 210 0278 ext 51526 takacs.istvan@med.semmelweis-univ.hu

Locations
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Hungary
Semmelweis University - Departement Medicine and Oncology Recruiting
Budapest, Hungary, 1083
Contact: Peter Lakatos, MD, DSc.    +36-1-210-0278 ext 51526    lakatos.peter@med.semmelweis-univ.hu   
Contact: Balazs Szili, MD    +36-1-210-0278 ext 51526    szili.balazs@med.semmelweis-univ.hu   
Principal Investigator: Istvan Takacs, MD, DSc.         
Sub-Investigator: Balazs Szili, MD         
Sub-Investigator: Bence Bakos, MD         
MediMOM Healthy Center Recruiting
Budapest, Hungary, 1112
Contact: Sándor Hamar, MD.         
Róbert Károly Hospital Recruiting
Budapest, Hungary, 1136
Contact: Pál Siklós, MD.         
Gynpraxis Nőgyógyászat Recruiting
Debrecen, Hungary, 4032
Contact: Attila Jakab, MD         
Somogy County Kaposi Mór Teaching Hospital Recruiting
Kaposvár, Hungary, 7400
Contact: Enikő Dezső, MD.         
Borsod-Abaúj-Zemplén County Hospital Recruiting
Miskolc, Hungary, 3526
Contact: Imre Molnár, MD.         
SZTE-ÁOK - 1st Dept. of Internal MEdicine Recruiting
Szeged, Hungary, 6720
Contact: Zsuzsanna Valkusz, MD.         
Gynofarm Outpatient Clinic Recruiting
Székesfehérvár, Hungary, 8600
Contact: Levente Rubliczky, MD.         
Sponsors and Collaborators
Semmelweis University
Pharma Patent Kft.
Investigators
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Principal Investigator: István Takács, MD, DSc. Semmelweis University - Dept. of Medicine and Oncology
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Responsible Party: Istvan Takacs, M.D., DSc., Director of Department, Semmelweis University
ClinicalTrials.gov Identifier: NCT04840238    
Other Study ID Numbers: PAT15-PCODD
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Vitamin D Deficiency
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents