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Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels (ECSPLOIT -D)

Primary Purpose

Heart Failure, Vitamin D Deficiency

Status

Unknown status

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

CHOLECALCIFEROL

PLACEBO

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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...)

Sites / Locations

Medicina Cardiovascolare - NOCSAE - Azienda USLRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CHOLECALCIFEROL

PLACEBO

Arm Description

Outcomes

Primary Outcome Measures

SIX MINUTE WALKING TEST DISTANCE

Secondary Outcome Measures

ECHOCARDIOGRAPHIC PARAMETERS

NEUROHORMONAL CHANGES

Full Information

NCT ID

NCT01477801

First Posted

November 18, 2011

Last Updated

November 18, 2011

Sponsor

Azienda Unita' Sanitaria Locale Di Modena

Collaborators

Abiogen Pharma

1. Study Identification

Unique Protocol Identification Number

NCT01477801

Brief Title

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

Acronym

ECSPLOIT -D

Official Title

Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels. A Phase 2 Randomized Double Blind Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Unknown status

Study Start Date

November 2011 (undefined)

Primary Completion Date

July 2012 (Anticipated)

Study Completion Date

September 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Azienda Unita' Sanitaria Locale Di Modena

Collaborators

Abiogen Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Vitamin D Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CHOLECALCIFEROL

Arm Type

Experimental

Arm Title

PLACEBO

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

CHOLECALCIFEROL

Other Intervention Name(s)

DIBASE (ABIOGEN PHARMA)

Intervention Description

Standard guideline based therapy plus cholecalciferol: Loading dose 300.000 U then 50.000 U every month for six months

Intervention Type

Drug

Intervention Name(s)

PLACEBO

Intervention Description

Standard guideline based therapy plus placebo

Primary Outcome Measure Information:

Title

SIX MINUTE WALKING TEST DISTANCE

Time Frame

six months

Secondary Outcome Measure Information:

Title

ECHOCARDIOGRAPHIC PARAMETERS

Time Frame

six months

Title

NEUROHORMONAL CHANGES

Time Frame

six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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...)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fabrizio Turrini, MD

Phone

0039593961100

f.turrini@ausl.mo.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fabrizio Turrini, MD

Organizational Affiliation

Azienda USL di Modena

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marco Bondi, MD

Organizational Affiliation

Azienda USL di Modena

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Paola Loria, MD

Organizational Affiliation

Università di Modena

Official's Role

Study Chair

Facility Information:

Facility Name

Medicina Cardiovascolare - NOCSAE - Azienda USL

City

Modena

State/Province

(mo)

ZIP/Postal Code

41100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fabrizio Turrini, MD

Phone

0039593961100

f.turrini@ausl.mo.it

First Name & Middle Initial & Last Name & Degree

Stefania Scarlini

12. IPD Sharing Statement

Learn more about this trial

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

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