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

Comparative Study of Intravenous Iron versus Intravenous Ascorbic Acid for Treatment of Anaemic Hemodialysis Patients with High Ferritin and Low Transferrin Saturation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201112248501N1
Enrollment
40
Registered
2012-01-21
Start date
2012-01-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Hemodialysis. Condition 2: Iron deficiency anaemia. Extracorporeal dialysis Iron deficiency anaemia, unspecified

Interventions

Intervention 1: Iron sucrose (Venofor st . Gallen/Switzerland) 100 mg diluted in 100 ml of Normal Saline, postdialysis, twice a week , during the first 5 weeks of the study in case group. Interventio
Treatment - Drugs
Iron sucrose (Venofor st . Gallen/Switzerland) 100 mg diluted in 100 ml of Normal Saline, postdialysis, twice a week , during the first 5 weeks of the study in case group.
Ascorbic acid 300 mg Intravenous postdialysis, twice a week for 5 consecutive weeks in control group.

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactOmid Sedighi

Mazandaran University of Medical Sciences

omid_sadighi2007@yahoo.com+98 15 1311 5225

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026