End-Stage Renal Disease, Erythropoietin, Oral Administration, Regular Hemodialysis, Vitamin C
Conditions
Brief summary
The study aimed to evaluate the safety and efficacy of oral vitamin C administration on erythropoietin dosing requirement in end-stage renal disease patients on regular hemodialysis.
Detailed description
Erythropoietin deficiency is the most significant cause of anemia in chronic kidney disease (CKD) and has been demonstrated to occur at each stage of kidney failure. Because the kidney is the sole source of erythropoietin (EPO) synthesis in adults, reduction in kidney mass as occurs in progressive CKD often results in impairment of EPO production, resulting in anemia. Vitamin C deficiency can interfere with iron absorption and utilization, as well as lead to various abnormalities. The occurrence of widespread vitamin C deficiency in dialysis patients calls for greater attention to these clinical problems. Ascorbic acid is low in patients with advanced CKD and end-stage renal disease (ESRD) due to dietary restrictions on vitamin C-rich foods, as these foods are usually also rich in potassium.
Interventions
DRUGNormal regimen of treatment of anemia
Patients were on normal regimen of treatment of anemia.
DRUGVitamin C
Patients were on 250 mg oral vitamin C daily for 3 months.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years. * Both sexes. * Stable hemodialysis (HD) for 90 days or more * Hemoglobin (HB) levels of 9-11 g/dL (as Hb levels above 11 g/dL, Epo dose reduction is recommended irrespective of iron level). * Erythropoietin (EPO) dose ≥4000 U/HD session and unchanged dose for two consecutive months * Ferritin level \>100 mcg/L. * Transferrin saturation (Tsat) of \<30 %. * Not on a vitamin C supplement. * Not receiving iron supplementation in the preceding 2 months. Each patient's previous 2-month stable dose of Epo was taken as the control.
Exclusion criteria
* Patients with gastrointestinal bleeding. * Blood transfusion, malignancy. * Hospital admission or history of noncompliance with dialysis and/or medication were excluded from the study and were also censored if these events occurred during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin level | 3 months post-procedure | Hemoglobin level was assessed every month for 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum iron level | 3 months post-procedure | Serum iron level was assessed every month for 3 months |
| Transferrin saturation | 3 months post-procedure | Transferrin saturation was assessed every month for 3 months |
| Change in erythropoietin dose | 3 months post-procedure | Change in erythropoietin dose was assessed every month for 3 months |
Countries
Egypt
Outcome results
None listed