30000 IU Per Week Vitamin D Treatment in PCOS Patients
Status:
Recruiting
Trial end date:
2021-09-01
Target enrollment:
Participant gender:
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