Clincosm LogoSign in Get a demo

Cholecalciferol Supplementation in Hemodialysis Patients

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT05922696
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
8.4
Actual Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Impact of Cholecalciferol Supplementation in Hemodialysis Patients
Actual Study Start Date :
May 15, 2022
Actual Primary Completion Date :
Sep 15, 2022
Actual Study Completion Date :
Jan 26, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group A

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

Drug: Cholecalciferol
50.000IU weekly in Group A , or 200.000IU monthly in Group B
Other Names:
  • Vitamin D3

    		•
    Active Comparator: Group B

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

    Drug: Cholecalciferol
    50.000IU weekly in Group A , or 200.000IU monthly in Group B
    Other Names:
  • Vitamin D3

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Increase serum 25-hydroxy vitamin D (25(OH)D) level to ≥ 30ng/ml [3 months]

    Secondary Outcome Measures

    1. Increase in hemoglobin (Hgb) levels (11-13 mg/dl), [3 months]

    2. TSAT levels to be ≥ 30% [3 months]

    3. Ferritin levels to be > 300 ng/ml, but not exceeding 800 ng/ml [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams University Hospital Cairo Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mona AlShahawey Ghazy, PhD, Assistant Professor of Clinical Pharmacy, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT05922696
    Other Study ID Numbers:
    • 152
    First Posted:
    Jun 28, 2023
    Last Update Posted:
    Jun 28, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vitamin D Deficiency
    Vitamin D
    Cholecalciferol

    Study Results

    No Results Posted as of Jun 28, 2023