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

Sponsor
Rajavithi Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04967469
Collaborator
(none)
60
1
3
44.9
1.3

Study Details

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

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Comparison of serum calcium level between patients who take Vitamin D and non-Vitamin D [4 year]

    Comparison of serum calcium level between patients who take Vitamin D and non-Vitamin D

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rajavithi Hospital Bangkok Thailand 10400

Sponsors and Collaborators

  • Rajavithi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rajavithi Hospital
ClinicalTrials.gov Identifier:
NCT04967469
Other Study ID Numbers:
  • 63127
First Posted:
Jul 19, 2021
Last Update Posted:
Sep 21, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rajavithi Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2021