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
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.
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.
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Cholecalciferol 30,000IU weekly orally
Placebo Comparator: Placebo
Placebo tablets weekly orally
- 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)
- Length of menstrual cycle [ Time Frame: Up to 32 weeks ]Determined by patient reported number of days between two menstrual cycles
- Variation in menstrual cycles length [ Time Frame: Up to 32 weeks ]Determined by patient reported menstrual cycle length and regularity, measured in days
- Incidence of adverse events [ Time Frame: Up to 32 weeks, continuously ]Incidence of adverse events (safety and tolerability), evaluated at every visit
- 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
- 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
- 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
- Change in fasting glucose level [ Time Frame: Up to 32 weeks ]Change in fasting glucose level (mmol/l), measured at every visit
- Change in hemoglobin A1c level [ Time Frame: Up to 32 weeks ]Change in hemoglobin A1c level (IFCC validated, mmol/mol), measured every 12 weeks
- 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)
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
|Contact: Pál Szamosújvári, MD||+36 1 630 61 email@example.com|
|Contact: István Takács, MD, DSc.||+36 210 0278 ext firstname.lastname@example.org|
|Semmelweis University - Departement Medicine and Oncology||Recruiting|
|Budapest, Hungary, 1083|
|Contact: Peter Lakatos, MD, DSc. +36-1-210-0278 ext 51526 email@example.com|
|Contact: Balazs Szili, MD +36-1-210-0278 ext 51526 firstname.lastname@example.org|
|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.|
|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.|
|Principal Investigator:||István Takács, MD, DSc.||Semmelweis University - Dept. of Medicine and Oncology|