Cholecalciferol on Hemodialysis Patients

Phase 2

Completed

• Conditions: Hemodialysis Complication; Vascular Calcification; Vitamin D Deficiency
• Interventions: Drug: Placebo; Drug: Cholecalciferol

• Registration Number: NCT03602430
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-07-01
• Study First Submitted QC: 2018-07-18
• Study First Posted: 2018-07-26
• Primary Completion: 2018-09-15
• Study Completion: 2018-09-28
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Both sexes aged between 18-75 years
2. Patients on HD greater than 3 months at least.
3. Stable clinical condition (no hospitalization in the previous 3 months)
4. Informed consent in accordance with the Declaration of Helsinki.
5. PTH level between 150 - 800 pg/ml.

Exclusion Criteria

1. Hypersensitivity to cholecalciferol.
2. Participant in an another clinical trial within the past 4 weeks.
3. Judged to be unsuitable as a subject by the attending physician.
4. Pregnant or breastfeeding female

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	twenty-five patients will receive a placebo ampule with their standard treatment for 3 months period.
Drug Group	Cholecalciferol	twenty-five patients will receive 200.000 IU/month native vitamin D; (Cholecalciferol) orally in addition to their standard treatment for 3 months period

Primary Outcome Measures

Name	Time	Method
Vitamin D level	3 months	Target serum Vitamin D level ≥ 30 ng/ml

Trial Locations

Locations (1)

Ain Shams University Hospital; 🇪🇬 Cairo, Egypt