60
Participants
Start Date
March 14, 2024
Primary Completion Date
March 14, 2026
Study Completion Date
June 14, 2026
Sucrosomial iron
"Sucrosomial iron with the addition at a fixed dose of vitamin C to promote iron absorption (SiderAL® Forte) will be administered orally once a day for 24 weeks.~The dose regimen for all participants will be calculated according to the haemoglobin (Hb) levels at baseline evaluation and to patient's body weight as follows:~Hb 14-16 g/dL: 1 tablet once a day, corresponding to 30 mg/daily, for 24 weeks; Hb 10-13.9 g/dL: 2 tablets once a day, corresponding to 60 mg/daily, for 24 weeks"
Placebo
"Placebo pills will be identical in shape, form and color of SI tablets; they will contain the same components of SiderAL Forte® except for sucrosomial iron and vitamin C.~Placebo will be administered orally once a day for 3 months according to the same dose scheme in the intervention arm."
RECRUITING
Azienda Ospedaliero Universitaria Pisana, Pisa
University of Pisa
OTHER
Raffaele De Caterina
OTHER