search
Back to results

30000 IU Per Week Vitamin D Treatment in PCOS Patients

Primary Purpose

Polycystic Ovary Syndrome, Vitamin D Deficiency

Status
Suspended
Phase
Phase 2
Locations
Hungary
Study Type
Interventional
Intervention
Cholecalciferol
Placebo
Sponsored by
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Semmelweis University - Departement Medicine and Oncology
  • MediMOM Healthy Center
  • Róbert Károly Hospital
  • Gynpraxis Nőgyógyászat
  • Somogy County Kaposi Mór Teaching Hospital
  • Borsod-Abaúj-Zemplén County Hospital
  • SZTE-ÁOK - 1st Dept. of Internal MEdicine
  • Gynofarm Outpatient Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cholecalciferol

Placebo

Arm Description

Cholecalciferol 30,000IU weekly orally

Placebo tablets weekly orally

Outcomes

Primary Outcome Measures

Recovery of ovarian function
Recovery of ovarian function is detected by changes in progesterone levels (lutal phase progesterone level reaches 2 ng/ml)

Secondary Outcome Measures

Length of menstrual cycle
Determined by patient reported number of days between two menstrual cycles
Variation in menstrual cycles length
Determined by patient reported menstrual cycle length and regularity, measured in days
Incidence of adverse events
Incidence of adverse events (safety and tolerability), evaluated at every visit
Change in serum calcium level
Change in serum calcium levels in mmol/l (safety measure), evaluated every clinical visit
Change in urinary calcium/creatinine ratio
Change in urinary calcium/creatinine ratio ([mmol/l]/[umol/l]) (safety measure), evaluated every clinical visit
25(OH)D levels
Evaluation of treatment of changes in 25(OH)D blood levels compared between treatment groups
Change in fasting glucose level
Change in fasting glucose level (mmol/l), measured at every visit
Change in hemoglobin A1c level
Change in hemoglobin A1c level (IFCC validated, mmol/mol), measured every 12 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)

Full Information

First Posted
July 14, 2020
Last Updated
November 8, 2022
Sponsor
Semmelweis University
Collaborators
Pharma Patent Kft.
search

1. Study Identification

Unique Protocol Identification Number
NCT04840238
Brief Title
30000 IU Per Week Vitamin D Treatment in PCOS Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
insufficient recruit activity
Study Start Date
December 8, 2016 (Actual)
Primary Completion Date
February 2022 (Actual)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semmelweis University
Collaborators
Pharma Patent Kft.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Vitamin D Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cholecalciferol
Arm Type
Experimental
Arm Description
Cholecalciferol 30,000IU weekly orally
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets weekly orally
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Intervention Description
30,000IU cholecalciferol
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets
Primary Outcome Measure Information:
Title
Recovery of ovarian function
Description
Recovery of ovarian function is detected by changes in progesterone levels (lutal phase progesterone level reaches 2 ng/ml)
Time Frame
Up to 32 weeks, continuously
Secondary Outcome Measure Information:
Title
Length of menstrual cycle
Description
Determined by patient reported number of days between two menstrual cycles
Time Frame
Up to 32 weeks
Title
Variation in menstrual cycles length
Description
Determined by patient reported menstrual cycle length and regularity, measured in days
Time Frame
Up to 32 weeks
Title
Incidence of adverse events
Description
Incidence of adverse events (safety and tolerability), evaluated at every visit
Time Frame
Up to 32 weeks, continuously
Title
Change in serum calcium level
Description
Change in serum calcium levels in mmol/l (safety measure), evaluated every clinical visit
Time Frame
Up to 32 weeks, continuously
Title
Change in urinary calcium/creatinine ratio
Description
Change in urinary calcium/creatinine ratio ([mmol/l]/[umol/l]) (safety measure), evaluated every clinical visit
Time Frame
Up to 32 weeks
Title
25(OH)D levels
Description
Evaluation of treatment of changes in 25(OH)D blood levels compared between treatment groups
Time Frame
Up to 32 weeks
Title
Change in fasting glucose level
Description
Change in fasting glucose level (mmol/l), measured at every visit
Time Frame
Up to 32 weeks
Title
Change in hemoglobin A1c level
Description
Change in hemoglobin A1c level (IFCC validated, mmol/mol), measured every 12 weeks
Time Frame
Up to 32 weeks
Title
Change in ovarian morphology
Description
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)
Time Frame
Up to 32 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Polycystic ovarian syndrome develops in only females
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
István Takács, MD, DSc.
Organizational Affiliation
Semmelweis University - Dept. of Medicine and Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Semmelweis University - Departement Medicine and Oncology
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
MediMOM Healthy Center
City
Budapest
ZIP/Postal Code
1112
Country
Hungary
Facility Name
Róbert Károly Hospital
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Gynpraxis Nőgyógyászat
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Somogy County Kaposi Mór Teaching Hospital
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Borsod-Abaúj-Zemplén County Hospital
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
SZTE-ÁOK - 1st Dept. of Internal MEdicine
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Gynofarm Outpatient Clinic
City
Székesfehérvár
ZIP/Postal Code
8600
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

30000 IU Per Week Vitamin D Treatment in PCOS Patients

We'll reach out to this number within 24 hrs