Cholecalciferol Supplementation in Hemodialysis Patients

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Cholecalciferol

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Ain Shams University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

TSAT levels to be ≥ 30%

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

Full Information

NCT ID

NCT05922696

First Posted

June 20, 2023

Last Updated

June 20, 2023

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT05922696

Brief Title

Cholecalciferol Supplementation in Hemodialysis Patients

Official Title

Impact of Cholecalciferol Supplementation in Hemodialysis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

May 15, 2022 (Actual)

Primary Completion Date

September 15, 2022 (Actual)

Study Completion Date

January 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Hemodialysis Complication, Vitamin D Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cholecalciferol

Other Intervention Name(s)

Vitamin D3

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

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

Time Frame

3 months

Title

TSAT levels to be ≥ 30%

Time Frame

3 months

Title

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Facility Information:

Facility Name

Ain Shams University Hospital

City

Cairo

Country

Egypt

Anemia, Hemodialysis Complication, Vitamin D Deficiency

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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