Clinical Trials Register

Summary
EudraCT Number:	2013-003546-16
Sponsor's Protocol Code Number:	1.2
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-02-12
Trial results	View 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

2013-003546-16

A.3

Full title of the trial

The Link between Obesity And Vitamin D in bariatric patients with omega-loop bypass surgery: a randomized controlled, double-blinded clinical supplementation trial - LOAD

LOAD - Der Zusammenhang zwischen Übergewicht und Vitamin D bei bariatrischen Patienten mit Omega-Loop Bypass Operation: eine randomisierte, kontrollierte, doppel-blinde klinische Supplementierungsstudie

A.3.1

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

The Link between Obesity And Vitamin D in bariatric patients with omega-loop bypass surgery

Der Zusammenhang zwischen Übergewicht und Vitamin D bei bariatrischen Patienten mit Omega-Loop Bypass Operation

A.3.2

Name or abbreviated title of the trial where available

LOAD

A.4.1

Sponsor's protocol code number

1.2

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 Wien, Klin. Abt. für Endokrinologie & Stoffwechsel, Universitätsklinik für Innere Medizin III
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	Medizinische Universität Wien, Klin. Abt. für Endokrinologie & Stoffwechsel, Universitätsklinik für Innere Medizin III
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 Wien, Klin. Abt. für Endokrinologie & Stoffwechsel, Universitätsklinik für Innere Medizin III
B.5.2	Functional name of contact point	Maria Luger
B.5.3	Address:
B.5.3.1	Street Address	Währinger Gürtel 18-20
B.5.3.2	Town/ city	Wien
B.5.3.3	Post code	1090
B.5.3.4	Country	Austria
B.5.4	Telephone number	00431404004364
B.5.5	Fax number	00431404004364
B.5.6	E-mail	maria.luger@meduniwien.ac.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.3.1	Product name	Oleovit D3-Tropfen
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.3.9.1	CAS number	0000067-97-0
D.3.9.2	Current sponsor code	not applicable
D.3.9.3	Other descriptive name	CHOLECALCIFEROL
D.3.9.4	EV Substance Code	SUB34314
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	14400
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

The aim of the study is to increase vitamin D concentrations respectively to keep it on high level by supplementing with cholecalciferol in a different dose regime, and to improve the overall health status in bariatric patients. In this project, the vitamin D status, the parameters of inflammation, bone turnover, insulin resistance and depression score of bariatric patients are expected to improve, due to supplementation of a loading dose compared to the standard therapy.

E.1.1.1

Medical condition in easily understood language

Vitamin D concentration, parameters of inflammation, bone turnover, insulin resistance and depression score are expected to improve, due to supplementation of a loading dose of vitamin D.

E.1.1.2

Therapeutic area

Body processes [G] - Physiological processes [G07]

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 test whether administering up to three doses of 100 000 IU vitamin D3 in the first month postoperatively (loading dose), followed by 3420 IU/day (intervention group LMD) in bariatric patients will increase significantly 25-hydroxyvitamin D levels 24 weeks after surgery, compared with a control group receiving placebo, followed by the standard daily doses of 3420 IU/ day (control group ST).

E.2.2

Secondary objectives of the trial

• Number of patients reaching 25-hydroxyvitamin D levels above 75 nmol/l in both groups (placebo and intervention)
• Prevalence of vitamin D deficiency in morbidly obese bariatric patients
• The expression of the 25-hydroxylases: CYP27A1, CYP2R1, CYP2J2, CYP3A4, CYP2C11, CYP27B1 (1α-hydroxylase), 24-hydroxylase (CYP24A1) and VDR genes by adipocytes in morbidly obese patients
• Measurement of vitamin D concentrations in two adipose tissue depots, visceral (VAT) and subcutaneous adipose tissue (SAT), and liver tissue at the time of omega loop bypass surgery (vitamin D storage in adipose and liver tissue)
• Change in body fat mass: by Dual energy X-Ray absorptiometry DEXA
• Change in blood pressure: systolic and diastolic (mmHg)
• Change in food intake: 5-day food record and Mediterranean Score
• Change in depression symptoms: Beck Depression Inventory (BDI Score)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Men and women over the age of 18 and under 100 years
Planned omega loop bypass surgery
25-OHD < 75 nmol/l
BMI > 40 or ≥ 35 kg/m2 with co-morbidities e.g. diabetes mellitus and hypertension
Body weight < 150 kg (due to limitation of DEXA measurement)
Capability to consent

E.4

Principal exclusion criteria

Another planned form of bariatric surgery
Hypercalcemia (calcium > 2.63 mmol/l) or hypocalcemia (calcium < 1.75 mmol/l)
Renal insufficiency (creatinine > 133 μmol/l or GFR < 50 ml/min)
Primary hyperparathyroidism
Malignancy
infection e.g. human immunodeficiency virus
(HIV)
Medical conditions requiring daily calcium
supplements or antacid use
Known hypersensitivity to cholecalciferol
No capability to consent
Imprisoned persons

E.5 End points

E.5.1

Primary end point(s)

25-OHD levels (nmol/l) after 24 weeks measured in intervention and control group, adjusting for the baseline value as covariate.

E.5.1.1

Timepoint(s) of evaluation of this end point

24 weeks postoperatively

E.5.2

Secondary end point(s)

Changes after 24 weeks between intervention and control group:
• Number of patients reaching 25-hydroxyvitamin D levels above 75 nmol/l
• Prevalence of vitamin D deficiency
• Co-morbidities,
• Prescribed medication,
• Body weight, body composition (lean body mass and fat),
• Vital signs (blood pressure),
• Laboratory parameter,
• Depression symptoms (BDI score),
• Bone mineral density and structure (DEXA and qCT),
• Liver condition (FibroScan® and CAPTM),
• Dietary assessment.

E.5.2.1

Timepoint(s) of evaluation of this end point

24 weeks postoperatively

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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

Yes

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

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.1.1.1

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)

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

F.3.3.1

Women of childbearing potential not using contraception

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

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)

Treatment or care after the subject has ended the participation in the trial is not different from the expected normal treatment.

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

2014-03-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-02-17

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-06-03

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