Cholecalciferol Supplementation in Hemodialysis Patients

Ain Shams University50 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Anemia Hemodialysis Complication Vitamin D Deficiency

Interventions

CholecalciferolDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ain Shams University Hospital

Cairo, Egypt

Outcomes

Primary Outcomes

Increase serum 25-hydroxy vitamin D (25(OH)D) level to ≥ 30ng/ml

Time frame: 3 months

Secondary Outcomes

Increase in hemoglobin (Hgb) levels (11-13 mg/dl),

Time frame: 3 months

TSAT levels to be ≥ 30%

Time frame: 3 months

Ferritin levels to be > 300 ng/ml, but not exceeding 800 ng/ml

Time frame: 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.