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NCT03249012 Clinical Trial

Quality of Life Related to Different Treatment Protocols for Post-thyroidectomy Hypoparathyroidism

Quality of Life Clinical Trial

Official title:
Comparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy Hypoparathyroidism

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03249012
Other study ID # 2018-3422
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date September 1, 2025

Study information
Verified date February 2023
Source CHU de Quebec-Universite Laval
Contact Jean-Philippe Vezina, MD, FRCSC
Phone 418-649-0252
Email jean-philippe.vezina@fmed.ulaval.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to compare two different protocols commonly used in the management of post thyroidectomy hypoparathyroidism : PTH based calcium repletion and empiric repletion. The investigators aim to compare the quality of life associated with these two protocols in a randomized trial.

Description:

Enrolled patients will be randomized in two treatment groups. In group 1, all patients will receive calcium carbonate and calcitriol in the post-operative period, with standardized weaning. In group 2, patients will be prescribed calcium carbonate and calcitriol only if their post-operative PTH dosage is 25% or less of the pre-operative dosage, or if post-operative PTH is inferior to 15. The Short-Form 36 (SF-36) questionnaire (French canadian version) will be used to assess quality of life pre-operatively and at post-op week 1 and 4. Symptoms of hypocalcemia and adverse effects of calcium carbonate and calcitriol will be monitored at week 1 and 4.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date September 1, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Total thyroidectomy or completion hemithyroidectomy Exclusion Criteria: - Need for neck dissection - Unable to fill in questionnaires (intellectual deficit, severe psychiatric disorder, illiterate, does not speak French or English)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Empiric use of Calcium Carbonate and Calcitriol
Empiric calcium carbonate and calcitriol repletion
• PTH based Calcium Carbonate and Calcitriol repletion
PTH based treatment

Locations
Country Name City State
Canada CHU de Quebec Québec Quebec

Sponsors (1)
Lead Sponsor Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline quality of life at 1 and 4 weeks Short Form 36 (SF-36) questionnaire Pre-op, 1 week post-op and 4 weeks post-op
Secondary Occurence and change in pharmacologic adverse effects of calcium carbonate and calcitriol A questionnaire about the adverse effects of calcium carbonate and calcitriol will be completed at post-op week 1 and 4 1 week post-op, 4 weeks post-op
Secondary Occurence and change in symptoms of hypocalcemia A questionnaire about symptoms of hypocalcemia will be completed at post-op week 1 and 4. 1 week post-op, 4 weeks post-op
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