Cholecalciferol Supplementation in Hemodialysis Patients

NCT05922696 | Completed Phase 2

• 1 other identifier: 152
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Anemia; Hemodialysis Complication; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (3)

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

  3 months

• TSAT levels to be ≥ 30%

  3 months

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

  3 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Drug: Cholecalciferol

Group B

ACTIVE COMPARATOR

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

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

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

Also known as: Vitamin D3

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• : 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Anemia; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pharmacy

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: June 28, 2023
• Study Start: May 15, 2022
• Primary Completion: September 15, 2022
• Study Completion: January 26, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

EG (1)