Cholecalciferol Supplementation in Hemodialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-15

Study Completion Date

2023-01-26

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

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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.

Conditions

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Anemia Hemodialysis Complication Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

Group A: Weekly Cholecalciferol: 25 eligible hemodialysis patients on oral cholecalciferol 50.000IU Cholecalciferol, once weekly, for 3 months' duration

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

50.000IU weekly in Group A , or 200.000IU monthly in Group B

Group B

Group b: Monthly Cholecalciferol: 25 eligible hemodialysis patients on oral cholecalciferol 200.00IU Cholecalciferol, once monthly, for 3 months' duration

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

50.000IU weekly in Group A , or 200.000IU monthly in Group B

Interventions

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Cholecalciferol

50.000IU weekly in Group A , or 200.000IU monthly in Group B

Intervention Type DRUG

Other Intervention Names

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Vitamin D3

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No