Clinical Trials Register

Summary
EudraCT Number:	2011-003183-75
Sponsor's Protocol Code Number:	752/11
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-12-23
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-003183-75

A.3

Full title of the trial

the role of vitamin D supplementation in the prevention of cardiovascular risk factors

Il ruolo della supplementazione con Vitamina D nella prevenzione dei fattori di rischio cardiovascolare

A.3.1

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

the role of vitamin D supplementation in the prevention of cardiovascular risk factors

Il ruolo della supplementazione con Vitamina D nella prevenzione dei fattori di rischio cardiovascolare

A.4.1

Sponsor's protocol code number

752/11

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	POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
B.1.3.4	Country	Italy
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	Policlinico Universitario Agostino Gemelli
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Policlinico Gemelli
B.5.2	Functional name of contact point	Endocr. e malattie del ricambio
B.5.3	Address:
B.5.3.1	Street Address	L.go Gemelli 8
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00168
B.5.3.4	Country	Italy
B.5.4	Telephone number	0630157094
B.5.5	Fax number	0630156193
B.5.6	E-mail	giaccari@rm.unicatt.it

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	DIBASE*OS SOLUZ 2,5ML 25000UI
D.2.1.1.2	Name of the Marketing Authorisation holder	ABIOGEN PHARMA SpA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	CHOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE FORM)
D.3.9.4	EV Substance Code	SUB11818MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25000
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

Obesity

Obesità

E.1.1.1

Medical condition in easily understood language

obesity

obesità

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10029883
E.1.2	Term	Obesity
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The purpose of this study is to evaluate whether caloric restriction in itself may be sufficient to restore the values of vitamin D in the normal range and if a further supplementation of vitamin D along with the diet can contribute to improve the cardiometabolic profile in obesity

valutare se la restrizione calorica di per sé possa essere sufficiente a ripristinare valori di vitamina D nel range di normalità e se un migliore apporto di vitamina D nella dieta possa contribuire a migliorare il profilo cardiometabolico nell’obesità, oltre alla restrizione calorica.

E.2.2

Secondary objectives of the trial

The secondary objective is to be able to understand if supplementation with vitamin D may be to enhance the beneficial effects resulting from the caloric restriction and when it does occur, to identify which parameters of vitamin D acts predominantly and to suggest pathogenic mechanisms behind.

Il secondo punto fondamentale è quello di riuscire a comprendere se la supplementazione con vitamina D possa andare a rafforzare gli effetti benefici conseguenti alla restrizione calorica e qualora così dovesse verificarsi, individuare su quali parametri la vitamina D agisce in maniera preponderante e ipotizzare i meccanismi patogenetici retrostanti

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

obese subjects aged ≥18 and ≤70 years

età compresa tra 18 e 70 anni, maschi e femmine, obesi

E.4

Principal exclusion criteria

1:fasting plasma glucose ≥ 126 mg/ or who report themselves to have diabetes or who take any oral glucose-lowering medication or insulin 2: resting BP > 140/90 mmHg or those who reported themselves to be hypertensive or those on any antihypertensive medication; 3: cholecalciferol or calcium supplementation in last 6 months; 4:chronic renal, hepatic, malignant or intestinal disease (self reported o r any suggestive medical documents) or renal stones; 5:any medication within the last month that could influence insulin secretion, insulin sensitivity, vitamin D or calcium metabolism (e.g. theophylline, phenytoin, β -blockers, diuretics, statins or renin–angiotensina system inhibitors, etc.); 6:febrile illness or infective morbidity in the last 10 days; and 7:grossly deranged liver (serum bilirubin > 34 μmol/l and serum glutamic pyruvic transaminase more than four times upper limit of normal) or kidney function (serum creatinine male ≥1.4 mg/dL (124 μmol/L); female ≥1.3 mg/dL (115 μmol/L). 8: heart disease and lung 9: primary and secondary hyperparathyroidism.

diagnosi nota di diabete assunzione di farmaci contenente vit. D o calcio

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is to evaluate the effects of vitamin D on insulinsensitivity evaluated by Hepatic fasting insulin sensitivity [homeostasis model assessment (HOMA), quantitative insulinsensitivity check index, HOMA-2], postprandial insulin sensitivity [oral glucose insulin sensitivity (OGIS)], insulin secretion (HOMA%B, HOMA2-%B) derived by oral glucose tolerance and insulin sensitivity evaluated by hyperinsulinemic euglycemic clamp.

valutare gli effetti della Vit. D sull'insulinosensibilità valutati mediante indici indiretti e diretti

E.5.1.1

Timepoint(s) of evaluation of this end point

6 months

6 mesi

E.5.2

Secondary end point(s)

Secondary outcome measures are: blood pressure, lipid profile, assessing body composition by DEXA, evaluation phospho-calcic metabolism (PTH, vitamin D, calcium); evaluation pattern of inflammation (IL6, IL10, adiponectin, TNF, C-reactive protein, fibrinogen), coagulation parameters of evaluation (analysis 3, lysis area, maximum absorbance capacity)

valutazione del profilo cardiovascolare

E.5.2.1

Timepoint(s) of evaluation of this end point

6 months

6 mesi

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

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

Yes

E.8.1.4

Double blind

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.8.4.1

Number of sites anticipated in 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

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

LVLS

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

Number of subjects for this age range:

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:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-12-23.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

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

2012-01-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-20

P. End of Trial
P.	End of Trial Status	Completed

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials