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

Azienda Unita' Sanitaria Locale Di Modena

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Vitamin D Deficiency; Heart Failure

Treatments: Drug: CHOLECALCIFEROL; Drug: PLACEBO

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01477801

MCV-MO-11-001

2011-001726-14 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 34 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No 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...)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups, including a placebo group

CHOLECALCIFEROL

Experimental group

Treatment:

Drug: CHOLECALCIFEROL

PLACEBO

Placebo Comparator group

Treatment:

Drug: PLACEBO