Beneficial Effects of Vitamin D Combined With Oral Iron Supplementation in Patients With Chronic Heart Failure and Iron Deficiency

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

258

Participants

Timeline

Start Date

January 15, 2024

Primary Completion Date

April 1, 2025

Study Completion Date

October 31, 2025

Conditions
Heart FailureIron-deficiencyHeart Failure, SystolicHeart Failure NYHA Class IIHeart Failure NYHA Class IIIVitamin D Deficiency
Interventions
DRUG

Sucrosomial iron

Sucrosomial iron group: administration of sucrosomial iron (SiderAl Forte®) at a dose of 60 mg (2 tablets) once a day for 24 weeks.

DRUG

Vitamin D

administration Vitamin D3 (100,000 IU load at time 0, then 2,000 IU daily) for 24 weeks in combination with of sucrosomial iron (SiderAl Forte®) at a dose of 60 mg (2 tablets) once daily in Sucrosomial iron and vitamin D group

DRUG

Ferric Carboxymaltose 50 MG/ML

Control group \[standard of care\]: administration of FCM (Ferinject®) with a dose between 500 and 2000 mg (depending on body weight and Hb values), to be administered in 1 or 2 doses (time 0 ± 6 weeks) with possible additional administration of 500 mg at week 12 in case of persistent ID.

All Listed Sponsors
lead

University of Padova

OTHER