MAGNESIUM L-ASPARTATE HYDROCHLORIDE TRIHYDRATE for Postoperative hypoparathyroidism

Inclusion criteria

• {"criterion_text":"- Adults aged 18–90 years scheduled for total thyroidectomy.\n- With or without lymph node dissection, for any benign or malignant indication.\n- Able to provide written informed consent.\n- No history of parathyroid disorder or calcium/magnesium metabolism disorder."}

Exclusion criteria

• {"criterion_text":"- Pre-existing hypoparathyroidism or hyperparathyroidism.\n- Renal insufficiency (eGFR <60 mL/min).\n- Active malabsorption syndromes.\n- Current or chronic use of magnesium supplementation.\n- Medications affecting calcium/magnesium (e.g., diuretics).\n- Known intolerance to magnesium therapy.\n- Unwillingness to comply with study visits or procedures.\n- Patients with comorbidities potentially exacerbated by magnesium supplementation, including: • Cardiac arrhythmias (e.g., AV block, bradyarrhythmias) • Myasthenia gravis • Severe gastrointestinal disorders affecting absorption (e.g., active IBD) • History of hypermagnesemia or magnesium toxicity • Concurrent use of medications with known magnesium interactions (e.g., aminoglycosides, digoxin, bisphosphonates, proton pump inhibitors)."}

Primary endpoints

• {"endpoint_text":"- Incidence of chronic postoperative hypoparathyroidism at 6 months post-surgery, defined by persistently low corrected calcium and PTH values in the absence of vitamin D or calcium discontinuation.","definition_or_measurement_approach":"Defined by persistently low corrected calcium and PTH values in the absence of vitamin D or calcium discontinuation; assessed at 6 months post-surgery."}

Secondary endpoints

• {"endpoint_text":"- Incidence of temporary hypoparathyroidism at 30 days.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Differences in replacement therapy needs (alfacalcidol, calcium carbonate, cholecalciferol) at Day 7, Month 1, 3, and 6.","definition_or_measurement_approach":"Comparison of replacement therapy needs for alfacalcidol, calcium carbonate and cholecalciferol at specified timepoints (Day 7; Month 1, 3, 6)."}
• {"endpoint_text":"- Safety/tolerability based on AE/SAE reports.","definition_or_measurement_approach":"Assessment based on reported adverse events (AEs) and serious adverse events (SAEs)."}
• {"endpoint_text":"- Patient-reported symptoms of hypocalcemia.","definition_or_measurement_approach":""}

Greece

Earliest CTIS Part Ii Submission Date

31-07-2025

Latest Decision Or Authorization Date

22-10-2025

Processing Time Days

83

Number Of Sites

1

Number Of Participants

500

Primary sponsor

Full Name

Henry Dunant Hospital Center

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Greece