Cholecalciferol Supplementation in Hemodialysis Patients

Phase 2

Completed

• Conditions: Anemia; Hemodialysis Complication; Vitamin D Deficiency
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT05922696
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2022-05-15
• Primary Completion: 2022-09-15
• Study Completion: 2023-01-26
• Status Verified: 2023-06
• Study First Submitted: 2023-06-20
• Study First Submitted QC: 2023-06-20
• Last Update Submitted: 2023-06-20
• Study First Posted: 2023-06-28
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Cholecalciferol	Group A: Weekly Cholecalciferol: 25 eligible hemodialysis patients on oral cholecalciferol 50.000IU Cholecalciferol, once weekly, for 3 months' duration
Group B	Cholecalciferol	Group b: Monthly Cholecalciferol: 25 eligible hemodialysis patients on oral cholecalciferol 200.00IU Cholecalciferol, once monthly, for 3 months' duration

Primary Outcome Measures

Name	Time	Method
Increase serum 25-hydroxy vitamin D (25(OH)D) level to ≥ 30ng/ml	3 months

Secondary Outcome Measures

Name	Time	Method
TSAT levels to be ≥ 30%	3 months
Ferritin levels to be > 300 ng/ml, but not exceeding 800 ng/ml	3 months
Increase in hemoglobin (Hgb) levels (11-13 mg/dl),	3 months

Trial Locations

Locations (1)

Ain Shams University Hospital; 🇪🇬 Cairo, Egypt