Clinical Trials Register

Summary
EudraCT Number:	2011-000994-30
Sponsor's Protocol Code Number:	VD1.3
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2013-01-24
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2011-000994-30

A.3

Full title of the trial

A randomized, double‐blind, placebo controlled trial to evaluate the effects of vitamin D supplementation on metabolic and fertility parameters in PCOS women

Einfluss einer Vitamin D-Supplementierung auf metabolische und endokrine Parameter bei Frauen mit Polycystischem Ovar-Syndrom-eine randomisierte kontrollierte Studie

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Vitamin D and pharmakogenetics in glucose metabolism

Vitamin D und Pharmakogenetik im Glucosestoffwechsel

A.4.1

Sponsor's protocol code number

VD1.3

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Medizinische Universität Graz
B.1.3.4	Country	Austria
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	FWF (Fonds zur Förderung der wissenschaftlichen Forschung)
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Medizinische Universität Graz
B.5.2	Functional name of contact point	Information für Klinische Studien
B.5.3	Address:
B.5.3.1	Street Address	Auenbruggerplatz 15
B.5.3.2	Town/ city	Graz
B.5.3.3	Post code	8045
B.5.3.4	Country	Austria
B.5.4	Telephone number	004331638581144
B.5.6	E-mail	elisabeth.lerchbaum@medunigraz.at

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Oleovit D3-Tropfen
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi Austria, Graz
D.2.1.2	Country which granted the Marketing Authorisation	Austria
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Oral drops
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Colecalciferol
D.3.9.3	Other descriptive name	CHOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE FORM)
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	14.400
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Oral drops
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Polycystic Ovary Syndrome

E.1.1.1

Medical condition in easily understood language

Women with high androgen levels, menstrual irregularities and polycystic ovaries

E.1.1.2

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To investigate the effect of vitamin D supplementation when compared to placebo on AUCgluc in women with polycystic ovary syndrome.

E.2.2

Secondary objectives of the trial

To investigate the effect of vitamin D supplementation when compared to placebo on insulin resistance, insulin sensitivity, hyperandrogenemia and fertility in women with polycystic ovary syndrome. To investigate pharmacogenetic effects of vitamin D-related genetic variants. In addition, gene expression analyses of relevant candidate genes in association with pathways of vitamin D, androgens and metabolism will be performed at each visit in order to analyze functional changes during vitamin D treatment

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

PCOS women:
1) Premenopausal women ≥18 years
2) Polycystic ovary syndrome: 2 out of the following criterias are required:
a) Oligo- or anovulation
b) Biochemical and/or clinical hyperandrogenism
c) Polycystic ovaries
3) 25(OH)D <30 ng/ml

Healthy women:
1) Premenopausal women ≥18 years
2) Exclusion of Polycystic ovary syndrome
3) 25(OH)D <30 ng/ml

E.4

Principal exclusion criteria

PCOS women:
Hypercalcemia
Withdrawn informed consent
Hormonal contraception in the last 3 months before entering the study
Insulin sensitizing agents in the last 6 months before entering the study
Lipid lowering agents and drugs affecting androgens and insulin sensitivity in the last 3 months before entering
the study
Vitamin D supplementation in the last 3 months before entering the study
Hyperandrogenism caused by other diseases than polycystic ovary syndrome (Cushing disease, adrenogenital
syndrome)

Healthy women:
diagnosed PCOS or any of the following criteria:
Oligo- or anovulation, Biochemical and/or clinical hyperandrogenism, Polycystic ovaries

Hypercalcemia
Withdrawn informed consent
Hormonal contraception in the last 3 months before entering the study
Insulin sensitizing agents in the last 6 months before entering the study
Lipid lowering agents and drugs affecting androgens and insulin sensitivity in the last 3 months before entering
the study
Vitamin D supplementation in the last 3 months before entering the study

E.5 End points

E.5.1

Primary end point(s)

25-OH-vitamin D, 1,25-OH-vitamin D, PTH
oral glucose tolerance test (glucose, insulin, C-peptide), AUCgluc, AUCins
HOMA-index, QUICKI, MATSUDA, Proinsulin
HbA1c, serum lipids

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks, 24 weeks

E.5.2

Secondary end point(s)

menstrual frequency
endocrine parameters (testosterone, free testosterone, SHBG, prolactin, androstendione, DHEAS, 17-OHprogesterone)
Lipometry
questionnaires, hirsutism-score (Ferriman-Gallway-score)
Transvaginal ultrasound
Genotypes-pharmacogenetic effects
Gene expression analyses (candidate genes: androgen receptor (AR), estrogen receptor (ER), aromatase (Cyp19), FOXL2 (Forkhead Box Protein L2), STAR (Steroidogenic acute regulatory protein), Cytochrom-P11, Cytochrom-P17, receptors of FSH and LH, SHBG, anti- und proinflammatory genes (Interleukines, Interferon, FOXP3 (forkhead box P3),…), genes related to glucose metabolism (IGF-1 (Insulin-like growth factor 1), IGF-1R (Insulin-like growth factor 1 Rezeptor), IGF-BP (Insulin-like growth factor binding proteins), INSL (Insulin-like peptides), insulin receptor (IR),…) and Vitamin D metabolism (Vitamin-D-Rezeptor (VDR), Cyp2R1, Cyp27A1, Cyp24A1, Cyp27B, as well as genes of TGF-beta superfamily (inhibin, activin und its receptors, follistatin, Transforming Growth Factors und its receptors, BMPs, AMH, Growth and Differentiation Factor 9 (GDF9)).

E.5.2.1

Timepoint(s) of evaluation of this end point

12 weeks, 24 weeks

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The last study visit (24 weeks after the first study visit) is the end of the trial

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

300

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

Yes

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

300

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Subjects will be treated with the normal treatment of that condition (according to the AES guidelines) after the subject has ended her participation in the trial.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-02-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-04-11

P. End of Trial
P.	End of Trial Status	Ongoing

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