Back to resultsComparison of Serum Calcium Level Between Preoperative Vitamin D and Non-vitamin D Regimen of Total Parathyroidectomy in End-stage Renal Failure Patients in Rajavithi Hospital
Primary Purpose
End Stage Renal Disease
Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Calcitriol
Alfacalcidol 0.5 MCG Oral Capsule
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring Hypocalcemia, Hyperparathyroidism, End Stage Renal Disease (ESRD), calcitriol
Eligibility Criteria
Inclusion Criteria:
- New End-stage renal failure patients and have iPTH>800 pg/dl at least 6 months
- Patients who no response hyperphosphatemia with high dose vitamin D
Exclusion Criteria:
- Allergy vitamin D
- Pregnancy
- Patients who parathyroidectomy have less than 4 gland
Sites / Locations
- Rajavithi HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
take calcitriol
take alphacalcidol
control
Arm Description
End-stage renal failure patients who is Hyperparathyroid with ESRD take calcitriol
End-stage renal failure patients who is Hyperparathyroid with ESRD take 1-hydroxycholecalciferol (alfacalcidol)
End-stage renal failure patients who is Hyperparathyroid with ESRD take standard treatment
Outcomes
Primary Outcome Measures
Comparison of serum calcium level between patients who take Vitamin D and non-Vitamin D
Comparison of serum calcium level between patients who take Vitamin D and non-Vitamin D
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04967469
Brief Title
Comparison of Serum Calcium Level Between Preoperative Vitamin D and Non-vitamin D Regimen of Total Parathyroidectomy in End-stage Renal Failure Patients in Rajavithi Hospital
Official Title
Comparison of Serum Calcium Level Between Preoperative Vitamin D and Non-vitamin D Regimen of Total Parathyroidectomy in End-stage Renal Failure Patients in Rajavithi Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This Research is compare about IV Calcium between end-stage renal failure patients who take vitamin D and non-vitamin D preoperative parathyroidectomy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Hypocalcemia, Hyperparathyroidism, End Stage Renal Disease (ESRD), calcitriol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
take calcitriol
Arm Type
Experimental
Arm Description
End-stage renal failure patients who is Hyperparathyroid with ESRD take calcitriol
Arm Title
take alphacalcidol
Arm Type
Experimental
Arm Description
End-stage renal failure patients who is Hyperparathyroid with ESRD take 1-hydroxycholecalciferol (alfacalcidol)
Arm Title
control
Arm Type
No Intervention
Arm Description
End-stage renal failure patients who is Hyperparathyroid with ESRD take standard treatment
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Intervention Description
end-stage renal failure patients who is hyperparathyroid with ESRD take calcidol preoperative Parathyroidectomy
Intervention Type
Drug
Intervention Name(s)
Alfacalcidol 0.5 MCG Oral Capsule
Intervention Description
end-stage renal failure patients who is hyperparathyroid with ESRD take alfacalcidol preoperative Parathyroidectomy
Primary Outcome Measure Information:
Title
Comparison of serum calcium level between patients who take Vitamin D and non-Vitamin D
Description
Comparison of serum calcium level between patients who take Vitamin D and non-Vitamin D
Time Frame
4 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
New End-stage renal failure patients and have iPTH>800 pg/dl at least 6 months
Patients who no response hyperphosphatemia with high dose vitamin D
Exclusion Criteria:
Allergy vitamin D
Pregnancy
Patients who parathyroidectomy have less than 4 gland
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Somjin Chindavijak, MD
Phone
0896937679
Email
jksomjin@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Serum Calcium Level Between Preoperative Vitamin D and Non-vitamin D Regimen of Total Parathyroidectomy in End-stage Renal Failure Patients in Rajavithi Hospital
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