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

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01477801

Acronym

ECSPLOIT -D

Enrollment

Registered

2011-11-23

Start date

2011-11-30

Completion date

2012-09-30

Last updated

2011-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Vitamin D Deficiency

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: 1. performance at six minutes walking test 2. echocardiographic parameters 3. neurohormonal imbalance

Interventions

DRUGCHOLECALCIFEROL

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

DRUGPLACEBO

Standard guideline based therapy plus placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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...)

Design outcomes

Primary

Measure	Time frame
SIX MINUTE WALKING TEST DISTANCE	six months

Secondary

Measure	Time frame
ECHOCARDIOGRAPHIC PARAMETERS	six months
NEUROHORMONAL CHANGES	six months

Countries

Italy

Contacts

Primary ContactFabrizio Turrini, MD

f.turrini@ausl.mo.it0039593961100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026