Calcium and Calcitriol Protocols for Hypoparathyroidism
Trial Summary
What is the purpose of this trial?
This trial is testing two ways to give calcium and vitamin D to patients with low hormone levels after thyroid surgery. One method gives supplements to everyone right away, while the other gives them only if hormone levels drop significantly. The goal is to see which method improves quality of life more.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the drug Calcium Carbonate and Calcitriol for treating hypoparathyroidism?
Calcium carbonate is commonly used in hypoparathyroidism treatment because it provides a high amount of elemental calcium, which is essential for managing the condition. Additionally, conventional therapy for hypoparathyroidism often includes calcium and activated vitamin D, like calcitriol, to maintain proper calcium levels in the blood.12345
Is calcium carbonate and calcitriol treatment safe for humans?
Calcium carbonate and calcitriol are generally safe for most people when used as directed, but excessive intake can lead to milk-alkali syndrome, which causes high calcium levels, kidney problems, and metabolic alkalosis (a condition where the body becomes too alkaline). People with certain conditions, like kidney issues or those taking specific medications, should be monitored for these risks.46789
How is the drug for hypoparathyroidism different from other treatments?
This treatment for hypoparathyroidism is unique because it combines calcium carbonate and calcitriol (an active form of vitamin D) with a focus on PTH (parathyroid hormone) based calcium repletion, which may help in better managing calcium levels compared to conventional treatments that rely solely on calcium and vitamin D supplements.1231011
Research Team
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive calcium carbonate and calcitriol post-operatively, with monitoring of PTH levels to determine treatment protocol
Follow-up
Participants are monitored for quality of life, symptoms of hypocalcemia, and adverse effects of treatment
Treatment Details
Interventions
- Empiric use of Calcium Carbonate and Calcitriol (Other)
- PTH based Calcium Carbonate and Calcitriol repletion (Other)
Empiric use of Calcium Carbonate and Calcitriol is already approved in Canada for the following indications:
- Symptomatic relief of heartburn, acid indigestion, and sour stomach
- Calcium supplementation
- Post-thyroidectomy hypocalcemia management
Find a Clinic Near You
Who Is Running the Clinical Trial?
CHU de Quebec-Universite Laval
Lead Sponsor