Clinical Trials Register

Summary
EudraCT Number:	2011-000868-95
Sponsor's Protocol Code Number:	DvitKOL01022011
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2011-05-03
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

Denmark - DHMA

A.2

EudraCT number

2011-000868-95

A.3

Full title of the trial

Vitamin D and COPD
A randomised, doubble-blind, placebo-controlled trial of the effect of vitamin D on withdrawal from pulmonary rehabilitation and exercise endurance

A.3.1

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

Vitamin D and COPD

A.3.2

Name or abbreviated title of the trial where available

DvitKOL

A.4.1

Sponsor's protocol code number

DvitKOL01022011

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	Hvidovre Hospital
B.1.3.4	Country	Denmark
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	Hvidovre Hospital
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	Pharma Vinci A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Hvidovre Hospital
B.5.2	Functional name of contact point	Lungemedicinsk Sektion
B.5.3	Address:
B.5.3.1	Street Address	Kettegård Allé 30
B.5.3.2	Town/ city	Hvidovre
B.5.3.3	Post code	2650
B.5.3.4	Country	Denmark
B.5.4	Telephone number	4538623165
B.5.5	Fax number	4538623615
B.5.6	E-mail	mia.moberg@hvh.regionh.dk

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	BioVinci Mega D-vitamin 38 mcg
D.2.1.1.2	Name of the Marketing Authorisation holder	Pharma Vinci A/S
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	Tablet
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.3.9.1	CAS number	67-97-0
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	38
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	Cholecalciferol is extracted from the fat from sheep wool

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	Tablet
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

Chronic obstructive pulmonary disease (COPD)

E.1.1.1

Medical condition in easily understood language

Chronic bronchitis, emphysema or "smoker's lung"

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10009032
E.1.2	Term	Chronic obstructive lung disease
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal 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

To examine the effect of vitamin D intervention in patients with chronic obstructive pulmonary disease (COPD) undergoing rehabilitation. The main objective being examination of the effect on withdrawal rates and walking distance

E.2.2

Secondary objectives of the trial

To examine the effect of vitamin D in patients with COPD relating to bone health, inflammation, health related quality of life, and infection

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Age ≥ 50 years
2) Diagnosed COPD with forced expiratory volume in 1 second (FEV1) < 70 % of predicted
3) Breathlessness relative to MRC dyspnoea grade 3 or more

1) Alder ≥ 50 år
2) Kendt med moderat, svær eller meget svær KOL iht. GOLD-kriterierne med forceret ekspiration i 1 sekund (FEV1) < 70 % af forventet
3) Åndenød svarende til MRC dyspnøskala grad 3 eller højere

E.4

Principal exclusion criteria

1) Patients with known diseases of bone metabolism apart from osteoporosis and patients with granulomatous disease
2) Patients with hyper- or hypocalcemia at inclusion
3) Patients with cardiovascular or musculoskeletal disease that impacts significantly on walking based on the investigator’s judgement
4) Patients with dementia or other mental conditions rendering them unable to understand the study information and thus provide informed consent
5) Patients with terminal disease or known cancer with bone metastases, increasing their risk of hypercalcemia
6) Patients taking more than 20 µg vtamin D on a daily basis who do not have vitamin D (serum 25-OHD) less than 40 nnmol/L. If a patient takes vitamin D, dose should have been stable 6 months prior to inclusion in order to achieve steady-state.
7) Pregnancy

1) Patienter med kendte knoglemetaboliske sygdomme fraset knogleskørhed samt patienter med granulomatøse lidelser
2) Patienter med for højt eller for lavt kalkindhold i blodet målt ved inklusion
3) Patienter med hjerte-karlidelse eller lidelse i bevægeapparatet, der influerer væsentlig på gangfunktionen efter investigators skøn
4) Patienter med demens eller andre mentale tilstande, der påvirker patientens evne til at underskrive et informeret samtykke og gennemføre et rehabiliteringsforløb
5) Patienter med terminal tilstand eller kendt aktiv cancer med knoglemetastaser, der signifikant øger risikoen for forhøjet kalkindhold i blodet
6) Patienter der indtager mere end 20 mikrogram D-vitamin dagligt, som ikke har 25-OHD mindre end 40 nmol/L. Hvis patienten tager D-vitamin, skal han/hun have taget dette i mindst 6 måneder inden inklusion
7) Gravide

E.5 End points

E.5.1

Primary end point(s)

1) Withdrawal rate from pulmonary rehabilitation
2) Walking distance assessed by ISWT and ESWT

E.5.1.1

Timepoint(s) of evaluation of this end point

After 24 weeks

E.5.2

Secondary end point(s)

1) Vitamin D status: se-25-OHD, se-PTH
2) Calcium metabolic status: se-calcium, se-fosfat and se-magnesium
3) Quality of life (CAT og SGRQ)
4) Bone metabolic status: Se-ICTP, -PINP and osteocalcin. BMD L1-L4 and BMD total hip (DXA-scan)
5) Fat free mass and fat mass: DXA-scan
6) Physical activity assessed by SenseWear Armband
7) COPD excacerbations, all hospital admissions and death

E.5.2.1

Timepoint(s) of evaluation of this end point

After 11 weeks, 24 weeks and 52 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

Yes

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

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

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

Four weeks after the last visit of the last patient undergoing the trial. The patient is followed four weeks after he/she has taken the last tablet as a control of side effects.

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1