Recruiting

Quality of Life

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT03249012

Conditions

Hypoparathyroidism Postprocedural

Quality of Life

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Empiric use of Calcium Carbonate and Calcitriol

PTH based Calcium Carbonate and Calcitriol repletion

Study Details

Brief 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.

Conditions

Hypoparathyroidism Postprocedural

Quality of Life

Study ID

NCT03249012

Start date

Sep 1, 2017

Status verified date

Aug, 2024

Completion date

Sep 1, 2025

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Empiric calcium and calcitriol repletion group

All patients in this group will receive post-operative calcium carbonate and calcitriol.

experimental: PTH based repletion group

Patients in this group will be prescribed calcium carbonate and calcitriol based on their post-operative PTH.

Interventions

Empiric use of Calcium Carbonate and Calcitriol

Empiric calcium carbonate and calcitriol repletion

PTH based Calcium Carbonate and Calcitriol repletion

PTH based treatment

Primary outcome measure

  • Change from baseline quality of life at 1 and 4 weeks [ Time Frame: Pre-op, 1 week post-op and 4 weeks post-op ]

Central Contacts and Locations

Central contacts

Jean-Philippe Vezina, MD, FRCSC

418-649-0252jean-philippe.vezina@fmed.ulaval.ca

Locations

CHU de Quebec

Recruiting

Québec, Quebec, Canada, G1J1Z4

Contacts

Jean-Philippe Vezina, MD

418-649-0252jean-philippe.vezina@fmed.ulaval.ca

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Aug 28, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2024-08-28.