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

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ClinicalTrials.gov Identifier: NCT03249012
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Jean-Philippe Vézina, CHU de Quebec-Universite Laval

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.

Condition or disease Intervention/treatment Phase
Hypoparathyroidism Postprocedural Quality of Life Other: Empiric use of Calcium Carbonate and Calcitriol Other: PTH based Calcium Carbonate and Calcitriol repletion Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy Hypoparathyroidism
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Experimental: Empiric calcium and calcitriol repletion group
All patients in this group will receive post-operative calcium carbonate and calcitriol.
Other: Empiric use of Calcium Carbonate and Calcitriol
Empiric calcium carbonate and calcitriol repletion

Experimental: PTH based repletion group
Patients in this group will be prescribed calcium carbonate and calcitriol based on their post-operative PTH.
Other: PTH based Calcium Carbonate and Calcitriol repletion
PTH based treatment




Primary Outcome Measures :
  1. Change from baseline quality of life at 1 and 4 weeks [ Time Frame: Pre-op, 1 week post-op and 4 weeks post-op ]
    Short Form 36 (SF-36) questionnaire


Secondary Outcome Measures :
  1. Occurence and change in pharmacologic adverse effects of calcium carbonate and calcitriol [ Time Frame: 1 week post-op, 4 weeks post-op ]
    A questionnaire about the adverse effects of calcium carbonate and calcitriol will be completed at post-op week 1 and 4

  2. Occurence and change in symptoms of hypocalcemia [ Time Frame: 1 week post-op, 4 weeks post-op ]
    A questionnaire about symptoms of hypocalcemia will be completed at post-op week 1 and 4.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249012


Contacts
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Contact: Jean-Philippe Vezina, MD, FRCSC 418-649-0252 jean-philippe.vezina@fmed.ulaval.ca

Locations
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Canada, Quebec
CHU de Quebec Recruiting
Québec, Quebec, Canada, G1J1Z4
Contact: Jean-Philippe Vezina, MD    418-649-0252    jean-philippe.vezina@fmed.ulaval.ca   
Sponsors and Collaborators
CHU de Quebec-Universite Laval

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Responsible Party: Jean-Philippe Vézina, Otolaryngologist and Head & Neck Surgeon, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT03249012     History of Changes
Other Study ID Numbers: 2018-3422
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Calcitriol
Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Calcium
Calcium, Dietary
Calcium Carbonate
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances