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| Name | Class |
|---|---|
| East Tallinn Central Hospital | OTHER |
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The goal of this clinical trial is to evaluate whether a lower-dose calcium replacement therapy is non-inferior to a higher-dose regimen in preventing symptomatic hypoparathyroidism in patients following thyroidectomy. The hypothesis is:
• lower-dose calcium replacement therapy is non-inferior to higher-dose therapy in preventing symptomatic hypoparathyroidism during the first two postoperative weeks
Researchers will compare patients receiving a lower-dose calcium replacement regimen with those receiving a higher-dose regimen to assess whether the lower dose is not associated with a higher incidence of symptomatic hypoparathyroidism.
Patients who develop post-thyroidectomy hypoparathyroidism are divided into groups for calcium replacement therapy. If they are asymptomatic, they will be scheduled for a follow-up visit at two weeks after surgery. During the follow-up visit, calcium metabolism will be evaluated, and treatment adjusted if necessary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower dose calcium replacement | Active Comparator | calcium carbonate 1250 mg x 2 |
|
| Higher dose calcium replacement | Active Comparator | calcium carbonate 1250 mg x 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium carbonate 1250 mg (500 mg elemental calcium) twice a day | Drug | One study group takes calcium carbonate 1250 mg (500 mg elemental calcium) twice a day (at lunchtime and in the evening) |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of symptomatic hypoparathyroidism | Occurrence of symptomatic hypoparathyroidism within 14 days postoperatively | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum calcium levels at 2 week follow-up | Comparison of serum calcium levels at the 2-week follow-up between lower- and higher-dose calcium replacement groups. | 2 weeks |
| Duration and permanence of hypoparathyroidism |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanna Hollman | Contact | +37259037517 | hanna.hollman@ut.ee | |
| Ceith Nikkolo | Contact | +372 53318092 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Tallinn Central Hospital | Recruiting | Tallinn | Other | 11914 | Estonia |
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| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| D002118 | Calcium |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
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This study evaluates different dosing regimens of a widely used calcium preparation; as the drug is already approved and commonly used, a clinical trial phase is not applicable
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| Calcium carbonate 1250 mg (500 mg elemental calcium) 4 times a day | Drug | The second study group takes 1250 mg of calcium carbonate (500 mg of elemental calcium) four times a day (starting at noon, at approximately 4-hour intervals: at noon, in the early afternoon, in the evening, and before bedtime). This dosage regimen is prescribed because 500 mg of calcium can be absorbed at a time. |
|
Assessment of whether postoperative hypoparathyroidism resolves (transient) or persists (permanent) during follow-up.
| Up to 12 months postoperatively |
| Serum parathyroid hormone (PTH) levels at 2 week follow-up | Comparison of serum parathyroid hormone (PTH) levels at the 2-week follow-up between lower- and higher-dose calcium replacement groups. | 2 weeks |
| Tartu University Hospital | Recruiting | Tartu | Estonia |
|
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |