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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
One study group takes calcium carbonate 1250 mg (500 mg elemental calcium) twice a day (at lunchtime and in the evening)
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.
East Tallinn Central Hospital
Tallinn, Other, Estonia
RECRUITINGTartu University Hospital
Tartu, Estonia
RECRUITINGOccurence of symptomatic hypoparathyroidism
Occurrence of symptomatic hypoparathyroidism within 14 days postoperatively
Time frame: 2 weeks
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.
Time frame: 2 weeks
Duration and permanence of hypoparathyroidism
Assessment of whether postoperative hypoparathyroidism resolves (transient) or persists (permanent) during follow-up.
Time frame: 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.
Time frame: 2 weeks
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