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Comparative Study of Intravenous Iron versus Intravenous Ascorbic Acid for Treatment of Functional Iron Deficiency in Hemodialysis Patients

Phase 2
Conditions
Condition 1: Hemodialysis. Condition 2: Iron deficiency anaemia.
Extracorporeal dialysis
Iron deficiency anaemia, unspecified
Registration Number
IRCT201112248501N1
Lead Sponsor
Mazandaran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
40
Inclusion Criteria

1) Ferritin level = 500ng/ml and TSAT= 25%; 2) Hemodialysis therapy for = 3 months; 3) Duration of recombinant human Erythropoietin (rHYEPO) treatment = 6 months at lest 6000 u/week; 4)Hemoglobin level < 11 gr/dl and Stable hemoglobin levels for four consecutive weeks; 5)The Hemodialysis patients= 18 years and<70 years. Exclusion criteria: 1) Blood transfusion during 3 months ago; 2) Blood loss during 3 months ago; 3) Acute infection; 4) Chronic inflammatory disease; 5) Active liver disease; 6) Hemoglobinopathy such as sickle cell disease; 7) Adminstration of intravenous Iron during 3 months ago.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Hemoglobin. Timepoint: Before the drug adminstration and at the 12 weeks after the start of drug adminstration. Method of measurement: computerized coulter counter(Abbot Machine made in USA).
Secondary Outcome Measures
NameTimeMethod
Sreum Ferritin. Timepoint: Before the drug adminstration and at the 12 weeks after the start of drug adminstration. Method of measurement: In ng/ml and will measure by LIAZON kit(made in Italy).;Serum Iron. Timepoint: Before the drug adminstration and at the 12 weeks after the start of drug adminstration. Method of measurement: In ng/ml and will measure by Pars Azmoon kit (made in Iran) and Hitachi analyzer (Model 911, made in Japan).;Total Iron Binding Capacity(TIBC). Timepoint: Before the drug adminstration and at the 12 weeks after the start of drug adminstration. Method of measurement: In mg/dl and will measure by Pars Azmoon kit(made in Iran) and Hitachi analyzer (Model 911, made in Japan).;Transferrin Saturation(TSAT). Timepoint: Before the drug adminstration and at the 12 weeks after the start of drug adminstration. Method of measurement: In Percent and will calculate by dividing serum Iron by TIBC x 100.
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