Effects of Cholecalciferol Supplementation in Patients Wi... | NCT01477801

Studies
Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels

NCT01477801

Sponsor

Azienda Unita' Sanitaria Locale Di Modena

Status

Unknown status

Last Update Posted

Nov 23, 2011Estimated

Enrollment

34Estimated

Phase

Phase 2Phase 3

Conditions

Heart Failure
Vitamin D Deficiency

Interventions

CHOLECALCIFEROL
PLACEBO

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-001726-14	EudraCT Number

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Jul 2012Estimated

Completion Date

Sep 2012Estimated

First Submitted Date

Nov 18, 2011

First Submission Date that Met QC Criteria

Nov 18, 2011

First Posted Date

Nov 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2011

Last Update Posted Date

Nov 23, 2011Estimated

Name	Class
Abiogen Pharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether cholecalciferol supplementation in patients with chronic heart failure and low vitamin D levels improves:

performance at six minutes walking test
echocardiographic parameters
neurohormonal imbalance

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CHOLECALCIFEROL	Experimental		Drug: CHOLECALCIFEROL
PLACEBO	Placebo Comparator		Drug: PLACEBO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CHOLECALCIFEROL	Drug	Standard guideline based therapy plus cholecalciferol: Loading dose 300.000 U then 50.000 U every month for six months	CHOLECALCIFEROL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SIX MINUTE WALKING TEST DISTANCE		six months

Secondary Outcomes

Measure	Description	Time Frame
ECHOCARDIOGRAPHIC PARAMETERS		six months
NEUROHORMONAL CHANGES		six months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Heart failure diagnosis according to European Society of Cardiology Guideline criteria
Age > 60 years old
25(OH) Vitamin D level < 30 ng/ml
Clinical and therapeutic stability for one month (NYHA class II or III)

Exclusion Criteria:

Chronic use of anticonvulsants or barbiturates, steroids, thiazides, aluminium or magnesium, colestipol or cholestyramine
Glomerular filtration rate lower than 30 ml/min/1.73 m2 according to MDRD equation
Nephrolitiasis, Sarcoidosis or hypercalcemia
Recent (three months) acute coronary syndrome or stroke or major vascular surgery
Reduced life expectancy due to other diseases (active neoplasms, liver cirrhosis...)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fabrizio Turrini, MD	Contact	0039593961100		f.turrini@ausl.mo.it

Overall Officials

Name	Affiliation	Role
Fabrizio Turrini, MD	Azienda USL di Modena	Principal Investigator
Marco Bondi, MD	Azienda USL di Modena	Study Director
Paola Loria, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medicina Cardiovascolare - NOCSAE - Azienda USL	Recruiting	Modena	(mo)	41100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001361	Avitaminosis
D003677	Deficiency Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided