Cholecalciferol on Hemodialysis Patients

Vitamin D Deficiency Clinical Trial

Official title:

Effect of Cholecalciferol on Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03602430
• Other study ID #: phCL 36
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 1, 2018
• Est. completion date: September 28, 2018

Study information

• Verified date: January 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 28, 2018
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• Hemodialysis Complication
• Vascular Calcification
• Vitamin D Deficiency

Intervention

Drug:
• Cholecalciferol
Native vitamin D dose of 200IU to be given once per month to hemodialysis patients
• Placebo
A Placebo ampule will be given to hemodialysis patients once per month with their standard treatment for 3 months period. Same color, odor and size, only without the active constituent.

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D level	Target serum Vitamin D level = 30 ng/ml	3 months