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

Summary

The goal of this randomized, controlled, open-label, interventional study is to evaluate whether, in patients with heart failure (HF) and iron deficiency (ID), the administration of vitamin D in combination with sucrosomial iron is as effective as intravenous ferric carboxymaltose in improving symptoms of HF.

The main hypothesis which the study aims to test is the non-inferiority of sucrosomial iron (± vitamin D) compared with FCM treatment, after 24 weeks. Primary endpoint: the performance of the Six-Minute Walking Test, comparing the mean difference from baseline of the distance walked by patients in meters.

Participants will be evaluated in outpatient scheduled visits at 6, 12 and 24 weeks, performing blood tests, clinical evaluation, instrumental investigations and recording any adverse events, cardiovascular events, re-hospitalizations and fractures.

The study will involve randomization into 3 groups with a 1:1:1 ratio:

1. Control group \[standard of care\]: administration of FCM (Ferinject®) with a dose between 500 and 2000 mg (depending on body weight and hemoglobin 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.
2. Sucrosomial iron group: administration of sucrosomial iron (SiderAl Forte®) at a dose of 60 mg (2 tablets) once a day for 24 weeks.
3. Sucrosomial iron and vitamin D group: administration of sucrosomial iron (SiderAl Forte®) at a dose of 60 mg (2 tablets) once daily + vitamin D3 (100,000 IU load at time 0, then 2,000 IU daily) for 24 weeks

Conditions

• Heart Failure
• Iron-deficiency
• Heart Failure, Systolic
• Heart Failure NYHA Class II
• Heart Failure NYHA Class III
• Vitamin 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.

Sponsors & Collaborators

• University of Padova

  lead OTHER

Principal Investigators

• Federico Capone, MD · University of Padova

• Roberto Vettor, MD · University of Padova

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-15

Primary Completion

2025-04-01

Completion

2025-10-31