Anemia, Hemodialysis Complication, Vitamin D Deficiency
Conditions
Brief summary
This is prospective single-blind randomized study, in Ain Shams University hospital) in Egypt, to assess the impact of Cholecalciferol on Anemia status in regular hemodialysis outpatients
Detailed description
This Srudy is to assess the Impact of Cholecalciferol on Anemia status in regular hemodialysis outpatients in terms of increase of Hgb \>11 g/dl, transferrin saturation (TSAT) of ≥ 30%, and ferritin levels to achieve a range of (300 to \< 800 ng/ml), and effect on Epoetin Dose needed. This study is also to adress the factors affecting the correcetion of Anemia by Cholecalciferol supplementation, such as oxidative stress and Inflammatory markers.
Interventions
DRUGCholecalciferol
50.000IU weekly in Group A , or 200.000IU monthly in Group B
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* : Male or female patients who are willing to participate in the trial should have been on maintenance hemodialysis sessions for not less than 3 months, aged between 18-70 years old, clinically stable (no prior hospitalization on the past three months), with serum 25(OH)D levels of less than 30 ng/ml and their iPTH levels of 150-800 pg/ml, and hemoglobin levels of less than 11 mg/dl.
Exclusion criteria
* Patients with previous or known hypersensitivity to cholecalciferol, * Patients who are already on cholecalciferol therapy, or patients on immunosuppressants. * Blood transfusion in the past 4 month, and patients who had anemia for other than renal causes, * Those who were participating in another clinical trial within the past 4 weeks or pregnant/breastfeeding female patients were excluded as well.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase serum 25-hydroxy vitamin D (25(OH)D) level to ≥ 30ng/ml | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Increase in hemoglobin (Hgb) levels (11-13 mg/dl), | 3 months |
| TSAT levels to be ≥ 30% | 3 months |
| Ferritin levels to be > 300 ng/ml, but not exceeding 800 ng/ml | 3 months |
Countries
Egypt
Outcome results
None listed