Cholecalciferol Supplementation in Hemodialysis Patients

Anemia Clinical Trial

Official title:

Impact of Cholecalciferol Supplementation in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05922696
• Other study ID #: 152
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 15, 2022
• Est. completion date: January 26, 2023

Study information

• Verified date: June 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 26, 2023
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Hemodialysis Complication
• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol
50.000IU weekly in Group A , or 200.000IU monthly in Group B

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase serum 25-hydroxy vitamin D (25(OH)D) level to = 30ng/ml		3 months
Secondary	Increase in hemoglobin (Hgb) levels (11-13 mg/dl),		3 months
Secondary	TSAT levels to be = 30%		3 months
Secondary	Ferritin levels to be > 300 ng/ml, but not exceeding 800 ng/ml		3 months