Comparing Different Oral Iron Dosing Regimens in Treatment of Iron Deficiency Anemia in Patients With Chronic Kidney Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 150
- Primary Endpoint
- Change in Hemoglobin level by gm/dl
Study Overview
Brief Summary
Comparing between the efficacy of alternate day oral iron dose, once daily and thrice daily dose in improving anemia in CKD patients
Detailed Description
Anemia is common in chronic kidney disease (CKD) and has been associated with impaired quality of life, cardiovascular disease (CVD) and mortality.
Iron deficiency is common in patients with CKD and an important modifiable factor in treatment of anemia.
In particular, the Kidney Disease: Improving Global Outcomes (KDIGO) anemia work group guidelines define anemia in CKD as a hemoglobin concentration of <13.0 g/dL in men and <12.0 g/dL in women. The current guidelines recommend trial of iron supplementation in CKD when increase in hemoglobin concentration or decrease in erythropoietin dose is desired and investigations reveal percentage transferrin saturation (%TSAT) ≤ 30% and serum ferritin ≤ 500 ng/ml.
The absorption of iron from gastro-intestinal tract and release of iron from reticuloendothelial cells for erythropoiesis are tightly regulated through hepcidin-ferroportin axis. Hepcidin concentrations increase in response to iron excess and inflammation. CKD is associated with elevated hepcidin and ferritin concentrations due to underlying inflammation, independent of iron status.
Iron-deficiency anemia in individuals with CKD may result from functional iron deficiency, absolute iron deficiency, or both. The factors contributing to functional iron deficiency are chronic inflammation and poor hepcidin clearance seen in CKD, whereas absolute iron deficiency includes poor gastrointestinal (GI) dietary iron absorption and blood loss.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All adult patients above 18 years old with CKD stages 2,3 and 4
Exclusion Criteria
- •CKD stage 5 (eGFR below 15 ).
- •Patients with hemolytic anemias.
- •Chronic liver diseases .
- •Autoimmune diseases.
- •Malignancy
- •History of blood transfusion last 3 months before the study
- •Pregnancy
- •Adult polycystic kidney disease ( APCKD)
Arms & Interventions
patients will receive oral iron in alternate day regimen
50 patients will receive oral ferrous sulphate in alternate day regimen
Intervention: Ferrous sulfate (Drug)
patients will receive oral iron in single daily dose regimen
50 patients will receive oral ferrous sulphate in single daily dose regimen
Intervention: Ferrous sulfate (Drug)
patients will receive oral iron in thrice daily dose regimen
50 patients will receive oral ferrous sulphate in thrice daily dose regimen
Intervention: Ferrous sulfate (Drug)
Outcomes
Primary Outcomes
Change in Hemoglobin level by gm/dl
Time Frame: 6 months
Follow up Hemoglobin level in 3 groups
Secondary Outcomes
No secondary outcomes reported
Investigators
Farrag Sayed Mohamed
Clinical physician
Assiut University