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

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01477801
• Other study ID #: MCV-MO-11-001
• Secondary ID: 2011-001726-14
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 18, 2011
• Last updated: November 18, 2011
• Start date: November 2011
• Est. completion date: September 2012

Study information

• Verified date: November 2011
• Source: Azienda Unita' Sanitaria Locale Di Modena
• Contact: Fabrizio Turrini, MD
• Phone: 0039593961100
• Email: f.turrini[@]ausl.mo.it
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

1. performance at six minutes walking test

2. echocardiographic parameters

3. neurohormonal imbalance

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: September 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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...)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Vitamin D Deficiency

Intervention

Drug:
• CHOLECALCIFEROL
Standard guideline based therapy plus cholecalciferol: Loading dose 300.000 U then 50.000 U every month for six months
• PLACEBO
Standard guideline based therapy plus placebo

Locations

Country	Name	City	State
Italy	Medicina Cardiovascolare - NOCSAE - Azienda USL	Modena	(mo)

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Unita' Sanitaria Locale Di Modena	Abiogen Pharma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SIX MINUTE WALKING TEST DISTANCE		six months	No
Secondary	ECHOCARDIOGRAPHIC PARAMETERS		six months	No
Secondary	NEUROHORMONAL CHANGES		six months	No