Cholecalciferol Supplementation in Hemodialysis Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Cholecalciferol Supplementation in Hemodialysis Patients

Conditions
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Anemia, Hemodialysis Complication, Vitamin D Deficiency

Intervention / Treatment
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* Drug: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Group A: Weekly Cholecalciferol: 25 eligible hemodialysis patients on oral cholecalciferol 50.000IU Cholecalciferol, once weekly, for 3 months' duration | Drug: Cholecalciferol<br>* 50.000IU weekly in Group A , or 200.000IU monthly in Group B<br>* Other names: Vitamin D3;|
| Active Comparator: Group B<br>Group b: Monthly Cholecalciferol: 25 eligible hemodialysis patients on oral cholecalciferol 200.00IU Cholecalciferol, once monthly, for 3 months' duration | Drug: Cholecalciferol<br>* 50.000IU weekly in Group A , or 200.000IU monthly in Group B<br>* Other names: Vitamin D3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase serum 25-hydroxy vitamin D (25(OH)D) level to ≥ 30ng/ml |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |