Iron-deficiency Clinical Trial
Official title:
Efficacy and Safety of Ferrous Iron on the Prevention of Vascular Cognitive Impairment Among Patients With Cerebral Infarction/TIA,FAVORITE
The prevalence of Vascular Cognitive Impairment(VCI) is high in patients after ischemic stroke or transient ischemic attack(TIA) . Effective therapy for the prevention of VCI remains limited. The primary purpose of this study is to evaluate the efficacy and safety of Ferrous iron versus placebo on the prevention of vascular cognitive impairment among patients with ischemic stroke/TIA complicated with Hemoglobin deficiency.
The prevalence of Vascular Cognitive Impairment(VCI) remains 21%~70% among patients after
ischemic stroke or TIA. Effective therapy for the prevention of VCI remains limited. Abnormal
iron distribution and Systemic iron deficiency may contribute partly to the occurrence of
VCI.The primary purpose of this study is to evaluate the efficacy and safety of Ferrous iron
versus placebo in reducing the risk of VCI at 1 year in patients with cerebral Infarction/TIA
complicated with Hemoglobin deficiency. The secondary purpose is to evaluate the effect of
Ferrous iron on the Biological markers of VCI; to evaluate the effect of iron supplement on
the outcome(death,stroke recurrence, dependency) of patients with ischemic stroke or TIA
complicated with Hemoglobin deficiency at 3 months/1 year after treatment.
This trial is a randomized, double-blind, placebo-controlled, multicenter clinical trial.
1006 patients in 20 centers in China will be enrolled with one of the following situations
1.recent ischemic stroke or TIA (within 3 months) with Fe deficiency （serum
ferritin<20µg/L）or Hemoglobin deficiency(<120g/L for female and <130g/L for male).2. Vascular
risk factors(hypertension, diabetes mellitus, or dyslipidemia), with multiply lacunar
infarctions(≥2) or extensive white matter lesions（Fazekas ≥2） or multiply
microhaemorrhage(≥2) showed on CT/Magnetic Resonance(MR) with Fe deficiency （serum
ferritin<20µg/L）or Hemoglobin deficiency(<120g/L for female and <130g/L for male).. Patients
will be randomly assigned into 2 groups according to the ratio of 1:1:
Ferrous iron therapy (0.2 per day) Placebo Face to face interviews will be made at baseline,
14 (or hospital discharge), 3th month± 7 days and 12th month ± 14 days after randomization.
Primary outcome is defined as prevalence of Vascular Cognition Impairment at 1 year after
treatment. Secondary outcomes include all-cause death; ischemic stroke; transient ischemic
attack; poor functional outcome (mRS 2-6). Safety outcomes, relating to adverse
gastrointestinal reactions and iron overload.
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