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Completed

NCT Number: NCT05922696

Cholecalciferol Supplementation in Hemodialysis Patients

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

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Key information

Conditions

Anemia Avitaminosis Deficiency Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemodialysis Complication Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University Hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cholecalciferol

Drug

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

Other names: Vitamin D3

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

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

    Time frame: 3 months

  2. TSAT levels to be ≥ 30%

    Time frame: 3 months

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

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Impact of Cholecalciferol Supplementation in Hemodialysis Patients

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 28, 2023
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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