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

January 24, 2024 updated by: Rajavithi Hospital
This Research is compare about IV Calcium between end-stage renal failure patients who take vitamin D and non-vitamin D preoperative parathyroidectomy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: take calcitriol
End-stage renal failure patients who is Hyperparathyroid with ESRD take calcitriol
Drug: Calcitriol
end-stage renal failure patients who is hyperparathyroid with ESRD take calcidol preoperative Parathyroidectomy
Experimental: take alphacalcidol
End-stage renal failure patients who is Hyperparathyroid with ESRD take 1-hydroxycholecalciferol (alfacalcidol)
Drug: Alfacalcidol 0.5 MCG Oral Capsule
end-stage renal failure patients who is hyperparathyroid with ESRD take alfacalcidol preoperative Parathyroidectomy
No Intervention: control
End-stage renal failure patients who is Hyperparathyroid with ESRD take standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of serum calcium level between patients who take Vitamin D and non-Vitamin D
Time Frame: 4 year
Comparison of serum calcium level between patients who take Vitamin D and non-Vitamin D
4 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajavithi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

July 8, 2021

First Posted (Actual)

July 19, 2021

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 63127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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