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Calcium and Calcitriol Protocols for Hypoparathyroidism
N/A
Recruiting
Research Sponsored by CHU de Quebec-Universite Laval
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Total thyroidectomy or completion hemithyroidectomy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week post-op, 4 weeks post-op
Awards & highlights
Study Summary
This trial will compare two protocols for treating post-thyroidectomy hypoparathyroidism. One protocol uses PTH to guide calcium repletion, while the other uses empiric repletion. The goal is to see which protocol results in a better quality of life for patients.
Who is the study for?
This trial is for individuals who have undergone a total thyroidectomy or completion hemithyroidectomy and are dealing with hypoparathyroidism. Participants must be able to complete questionnaires in English or French, without severe psychiatric disorders, intellectual deficits, illiteracy, or the need for neck dissection.Check my eligibility
What is being tested?
The study compares two treatment protocols for managing low parathyroid hormone levels after thyroid surgery: one uses PTH levels to determine calcium and vitamin D dosing (Calcitriol), while the other uses a fixed dose regardless of PTH levels.See study design
What are the potential side effects?
Potential side effects may include variations in calcium levels leading to symptoms like tingling sensations, muscle cramps or spasms. Overdosing could cause high calcium symptoms such as stomach pain, constipation, confusion, or kidney stones.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had my entire thyroid or half of it surgically removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week post-op, 4 weeks post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week post-op, 4 weeks post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline quality of life at 1 and 4 weeks
Secondary outcome measures
Occurence and change in pharmacologic adverse effects of calcium carbonate and calcitriol
Occurence and change in symptoms of hypocalcemia
Trial Design
2Treatment groups
Experimental Treatment
Group I: PTH based repletion groupExperimental Treatment1 Intervention
Patients in this group will be prescribed calcium carbonate and calcitriol based on their post-operative PTH.
Group II: Empiric calcium and calcitriol repletion groupExperimental Treatment1 Intervention
All patients in this group will receive post-operative calcium carbonate and calcitriol.
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Who is running the clinical trial?
CHU de Quebec-Universite LavalLead Sponsor
166 Previous Clinical Trials
106,874 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had my entire thyroid or half of it surgically removed.I need surgery to remove lymph nodes in my neck.
Research Study Groups:
This trial has the following groups:- Group 1: Empiric calcium and calcitriol repletion group
- Group 2: PTH based repletion group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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