CompletedInterventionalPhase 2Updated Mar 14, 2025
Cholecalciferol on Hemodialysis Patients | NCT03602430 | Trialant
CompletedInterventionalPhase 2Phase 3Updated Jan 9, 2019
Cholecalciferol on Hemodialysis Patients
Effect of Cholecalciferol on Hemodialysis Patients
ClinicalTrials.gov ID
NCT03602430
Lead Sponsor
Ain Shams UniversityOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2Phase 3
Enrollment
60Actual
Last Update Posted
Jan 9, 2019Actual
Start Date
Jul 1, 2018Actual
Primary Completion Date
Sep 15, 2018Actual
Completion Date
Sep 28, 2018Actual
Official Title
Effect of Cholecalciferol on Hemodialysis Patients
Brief Summary
Screening the prevalence of vitamin D deficiency among Egyptian hemodialysis patients on a single center (Ain Shams University hospital).
Assessing the effect of the native type of vitamin D (Cholecalciferol) on replenishing its deficiency via extra-renal vitamin D receptors (VDR), among Egyptian hemodialysis patients.
Assessing the effect of cholecalciferol on vascular calcification among Egyptian hemodialysis patients.
Assessing the effect of cholecalciferol on Blood pressure, parathyroid hormone.
Hemodialysis Complication
Vitamin D Deficiency
Vascular Calcification
Cholecalciferol
Placebo
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Both sexes aged between 18-75 years
Patients on HD greater than 3 months at least.
Stable clinical condition (no hospitalization in the previous 3 months)
Informed consent in accordance with the Declaration of Helsinki.
PTH level between 150 - 800 pg/ml.
Exclusion Criteria:
Hypersensitivity to cholecalciferol.
Participant in an another clinical trial within the past 4 weeks.
Judged to be unsuitable as a subject by the attending physician.