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

NCT04967469 | Completed DMC

• 1 other identifier: 63127
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

End Stage Renal Disease

Keywords

Hypocalcemia; Hyperparathyroidism; End Stage Renal Disease (ESRD); calcitriol

Outcome Measures

Primary Outcomes (1)

• 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

  4 year

Study Arms (3)

take calcitriol

EXPERIMENTAL

End-stage renal failure patients who is Hyperparathyroid with ESRD take calcitriol

Drug: Calcitriol

take alphacalcidol

EXPERIMENTAL

End-stage renal failure patients who is Hyperparathyroid with ESRD take 1-hydroxycholecalciferol (alfacalcidol)

Drug: Alfacalcidol 0.5 MCG Oral Capsule

control

NO INTERVENTION

End-stage renal failure patients who is Hyperparathyroid with ESRD take standard treatment

Interventions

Calcitriol DRUG

end-stage renal failure patients who is hyperparathyroid with ESRD take calcidol preoperative Parathyroidectomy

take calcitriol

Alfacalcidol 0.5 MCG Oral Capsule DRUG

end-stage renal failure patients who is hyperparathyroid with ESRD take alfacalcidol preoperative Parathyroidectomy

take alphacalcidol

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Allergy vitamin D
• Pregnancy
• Patients who parathyroidectomy have less than 4 gland

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Hypocalcemia; Hyperparathyroidism

Interventions

Calcitriol; alfacalcidol

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 19, 2021
• Study Start: September 1, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 25, 2024

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)