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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 below
Select...
I have had my entire thyroid or half of it surgically removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week post-op, 4 weeks post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week post-op, 4 weeks post-op for reporting.

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.

Find a Location

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor
166 Previous Clinical Trials
106,874 Total Patients Enrolled

Media Library

Empiric use of Calcium Carbonate and Calcitriol Clinical Trial Eligibility Overview. Trial Name: NCT03249012 — N/A
Hypoparathyroidism Research Study Groups: Empiric calcium and calcitriol repletion group, PTH based repletion group
Hypoparathyroidism Clinical Trial 2023: Empiric use of Calcium Carbonate and Calcitriol Highlights & Side Effects. Trial Name: NCT03249012 — N/A
Empiric use of Calcium Carbonate and Calcitriol 2023 Treatment Timeline for Medical Study. Trial Name: NCT03249012 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~21 spots leftby Sep 2025