Back to resultsCholecalciferol on Hemodialysis Patients
Primary Purpose
Hemodialysis Complication, Vitamin D Deficiency, Vascular Calcification
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Cholecalciferol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hemodialysis Complication
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.
- Pregnant or breastfeeding female
Sites / Locations
- Ain Shams University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Drug Group
Placebo Group
Arm Description
twenty-five patients will receive 200.000 IU/month native vitamin D; (Cholecalciferol) orally in addition to their standard treatment for 3 months period
twenty-five patients will receive a placebo ampule with their standard treatment for 3 months period.
Outcomes
Primary Outcome Measures
Vitamin D level
Target serum Vitamin D level ≥ 30 ng/ml
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03602430
Brief Title
Cholecalciferol on Hemodialysis Patients
Official Title
Effect of Cholecalciferol on Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
September 15, 2018 (Actual)
Study Completion Date
September 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis Complication, Vitamin D Deficiency, Vascular Calcification
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug Group
Arm Type
Experimental
Arm Description
twenty-five patients will receive 200.000 IU/month native vitamin D; (Cholecalciferol) orally in addition to their standard treatment for 3 months period
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
twenty-five patients will receive a placebo ampule with their standard treatment for 3 months period.
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Native vitamin D
Intervention Description
Native vitamin D dose of 200IU to be given once per month to hemodialysis patients
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vitamin D level
Description
Target serum Vitamin D level ≥ 30 ng/ml
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
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.
Pregnant or breastfeeding female
Facility Information:
Facility Name
Ain Shams University Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33594986
Citation
Alshahawey M, El Borolossy R, El Wakeel L, Elsaid T, Sabri NA. The impact of cholecalciferol on markers of vascular calcification in hemodialysis patients: A randomized placebo controlled study. Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):626-633. doi: 10.1016/j.numecd.2020.09.014. Epub 2020 Sep 21.
Results Reference
derived
Learn more about this trial
Cholecalciferol on Hemodialysis Patients
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