Clinical Trials Register

Summary
EudraCT Number:	2018-003313-17
Sponsor's Protocol Code Number:	VIT_D_2018
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-02-10
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2018-003313-17

A.3

Full title of the trial

Efficacy of vitamin D supplementation in patients with depressive disorder or bipolar disorder: randomized controlled clinical trial

Efficacia della supplementazione con vitamina d in pazienti con disturbo depressivo o disturbo bipolare: studio clinico controllato randomizzato

A.3.1

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

Efficacy of vitamin D supplementation in patients with depressive disorder or bipolar disorder: randomized controlled clinical trial

Efficacia della supplementazione con vitamina d in pazienti con disturbo depressivo o disturbo bipolare: studio clinico controllato randomizzato

A.3.2

Name or abbreviated title of the trial where available

VIT_D_2018

A.4.1

Sponsor's protocol code number

VIT_D_2018

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	AZIENDA OSPEDALIERA UNIVERSITARIA SENESE
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	Abiogen
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	Azienda Ospedaliera Universitaria Senese
B.5.2	Functional name of contact point	UOC Medicina Interna 1
B.5.3	Address:
B.5.3.1	Street Address	Viale Bracci 16
B.5.3.2	Town/ city	Siena
B.5.3.3	Post code	53100
B.5.3.4	Country	Italy
B.5.4	Telephone number	0577586450
B.5.5	Fax number	0577586450
B.5.6	E-mail	ranuccio.nuti@unisi.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 - "50.000 U.I./2,5 ML SOLUZIONE ORALE" 1 CONTENITORE MONODOSE DA 2,5 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	ABIOGEN PHARMA S.P.A.
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.3.1	Product name	DIBASE
D.3.2	Product code	[DIBASE]
D.3.4	Pharmaceutical form	Oral drops, solution
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	COLECALCIFEROLO
D.3.9.2	Current sponsor code	Dibase
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	50000
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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, solution
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

patients with major depressive disorder or bipolar disorder

pazienti affetti da disturbo depressivo maggiore o disturbo bipolare

E.1.1.1

Medical condition in easily understood language

patients with major depressive disorder or bipolar disorder

pazienti affetti da disturbo depressivo maggiore o disturbo bipolare

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Behaviours [F01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10057667
E.1.2	Term	Bipolar disorder
E.1.2	System Organ Class	10037175 - Psychiatric 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

Evaluation of the effect of treatment with cholecalciferol in subjects with depressive disorder or bipolar disorder after 12 weeks.

Valutazione dell'effetto del trattamento con colecalciferolo in soggetti con disturbo depressivo o dispturbo bipolare dopo 12 settimane.

E.2.2

Secondary objectives of the trial

Evaluation of the effect of treatment with cholecalciferol in subjects with depressive disorder or bipolar dysplasia after 24 weeks.
Evaluation of vitamin D status at 12 and 24 weeks.

Valutazione dell'effetto del trattamento con colecalciferolo in soggetti con disturbo depressivo o dispturbo bipolare dopo 24 settimane .
Valutazione dello stato vitaminico D alla 12 e 24 settimana.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age between 18 and 75 years
Subjects involved in the psychiatric services of the UOC of Psychiatry of the AOUS both hospitalized in the ordinary or Day Hospital and treated as outpatients with a diagnosis of major depressive disorder or bipolar disorder
MADRS score> 15
Levels of 25 (OH) Vitamin D <20 ng / ml
Patients on antipsychotic therapy should be on a stable dose of medication for at least two weeks
Patients able to take vitamin D supplementation by mouth
Availability to provide their free and informed consent.

Età tra 18 e i 75 anni
Soggetti afferenti ai servizi psichiatrici della UOC di Psichiatria della AOUS sia ricoverati in regime ordinario o di Day Hospital sia trattati in regime ambulatoriale con una diagnosi di disturbo depressivo maggiore o disturbo bipolare
MADRS score >15
Livelli di 25(OH)Vitamina D< 20 ng/ml
I pazienti in terapia antipsicotica devono essere in trattamento ad una dose stabile di farmaci da almeno due settimane
Pazienti in grado di assumere la supplementazione di Vitamina D per via orale
Disponibilità a fornire il proprio consenso libero e informato.

E.4

Principal exclusion criteria

Patients will not be included in the study if only one of the following exclusion criteria will be present:
Osteoporosis or previous fragility fractures
Osteomalacia or Paget's disease
Known disorders for interference with vitamin D metabolism (sarcoidosis, hypercalcaemia, renal failure)
Pregnancy or breastfeeding
Secondary osteoporosis (primary or secondary hyperparathyroidism, hyperprolactinemia, etc ...)
Taking estrogen, drugs for the treatment of osteoporosis or drugs known to have interference on bone metabolism (antiepileptics, cortisones, antiretrovirals, heparin etc ..)
Type 1 and 2 diabetes mellitus
Lipid metabolism disorders
Body Mass Index lower than 18 or greater than 34.9 kg / sqm
Abuse of narcotic substances
Administration of calcifediol, calcitriol, cholecalciferol or calcium supplementation in progress or in the previous two months
Neoplastic pathologies or severe hepatic, renal or gastrointestinal diseases
Severe cognitive disorder
Acute psychosis
Inability to answer questions
Refusal to sign informed consent

I Pazienti non potranno essere inclusi nello studio se sarà presente anche solamente uno solo dei criteri di esclusione di seguito riportati:
Osteoporosi o pregresse fratture da fragilità
Osteomalacia o morbo di Paget
Patologie note per avere interferenza con il metabolismo della vitamina D (sarcoidosi, ipercalcemia, insufficienza renale)
Gravidanza o allattamento
Osteoporosi secondarie (iperparatiroidsmo primitivo o secondario, iperprolattinemia, etc...)
Assunzione di estrogeni, farmaci per il trattamento dell'osteoporosi o farmaci noti per avere interferenza sul metabolismo osseo (antiepilettici, cortisonici, antiretrovirali, eparina etc..)
Diabete mellito di tipo 1 e 2
Disturbi del metabolismo lipidico
Body Mass Index inferiore a 18 o superiore a 34.9 kg/mq
Abuso di sostanze stupefacenti
Somministrazione di calcifediolo, calcitriolo, colecalciferolo o supplementazione di calcio in corso o nei due mesi precedenti
Patologie neoplastiche o gravi patologie epatiche, renali o gastrointestinali
Disturbo cognitivo grave
Psicosi acuta
Incapacità a rispondere alle domande
Rifiuto di firmare il consenso informato

E.5 End points

E.5.1

Primary end point(s)

Change in Montgomery-Asberg Depression Rating Scale -MADRS at 12 weeks of treatment
time of remission of depressive disorder (Montgomery-Asberg Depression Rating Scale -MADRS= 10)

Variazione del Montgomery-Asberg Depression Rating Scale -MADRS alla 12 settimana di trattamento
tempo di remissione del disturbo depressivo ( Montgomery-Asberg Depression Rating Scale -MADRS= 10)

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months

12 mesi

E.5.2

Secondary end point(s)

secondary:
Variations of the Montgomery-Asberg Depression Rating Scale (MADRS) score of 24 weeks
Changes in vitamin D 25OH levels at 12 and 24 weeks.

exploratory
Change in IL-6 and TNF-alpha levels at 12 and 24 weeks

Secondari:
Variazioni del Montgomery-Asberg Depression Rating Scale (MADRS) score alla24 settimana
Variazioni dei livelli di 25OH vitamina D alla 12 e 24 settimana.

Esplorativi
Variazione dei livelli di IL-6 e TNF-alpha alla 12 e 24 settimana

E.5.2.1

Timepoint(s) of evaluation of this end point

12 and 24 months

12 e 24 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

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)

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.8.4.1

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

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

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

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:

120

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

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

150

F.4.2

For a multinational trial

F.4.2.1

In the EEA

150

F.4.2.2

In the whole clinical trial

150

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)

It will be the Investigator's responsibility to follow the Patients, for an appropriate period of time, in relation to the event that determined their withdrawal from the study, in order to verify the clinical conditions, any laboratory tests, and / or the appearance of adverse events. even after some time from the termination of study therapy.

Sarà cura dello Sperimentatore seguire i Pazienti, per un periodo di tempo appropriato, in relazione all’evento che ha determinato il loro ritiro dallo studio, in maniera da verificare le condizioni cliniche, eventuali controlli di laboratorio, e/o la comparsa di eventi avversi anche a distanza di tempo dalla cessazione della terapia in studio.

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

2019-05-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-01-22

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

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