Clinical trial · Interventional
Calcium+Calcitriol Versus PTH for the Prevention of Hypocalcemia in Thyroidectomy. Randomized Clinical Trial
Comparison of Routine Prophylactic Calcium + Calcitriol and Selective Use Based on PTH for the Prevention of Postoperative Hypocalcemia in Patients With Total Thyroidectomy. Randomized Clinical Trial
NCT05252884CI-TRIAL-00085620completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this study is to compare the frequency of post-thyroidectomy symptomatic and biochemical hypocalcaemia between the strategy of routine prophylactic calcium + calcitriol vs the administration of calcium guided by PTH values.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Goiter | — | UNRESOLVED | — |
| Hyperthyroidism | — | UNRESOLVED | — |
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
| Thyroiditis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcium correction according to PTH levels | Diagnostic Test | — | UNRESOLVED |
| routine postoperative calcium and calcitriol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- calcium correction according to PTH levels
- description
- A PTH blood test will be performed 4 hours post-thyroidectomy.
- interventionNames
- Diagnostic Test: calcium correction according to PTH levels
- type
- ACTIVE_COMPARATOR
- label
- routine postoperative calcium and calcitriol
- description
- The patient will receive Calcium carbonate + calcitriol
- interventionNames
- Drug: routine postoperative calcium and calcitriol
Primary outcomes (1)
- measure
- symptomatic hypocalcaemia
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Patients undergoing total thyroidectomy who meet the following criteria: Patients over 18 years of age, Benign (goiter, thyroiditis, hyperthyroidism) or malignant (carcinoma) diagnosis, Patients who agree to participate in the study and sign the informed consent. Exclusion Criteria: \- Patients with parathyroid surgery in conjunction with thyroidectomy, Patients with prior parathyroid disease for other causes (hyperparathyroidism primary or secondary to kidney disease, etc.), Patients with anaplastic carcinoma or lymphoma, Patients undergoing total thyroidectomy for causes other than thyroid disease such as, for example, total laryngectomy or pharyngo-laryngectomy that, due to margins or direct extension, require thyroidectomy. , Altered cognitive state that interfered or made the evaluation impossible.
References
Publications (15)
- BACKGROUNDAbboud B, Sargi Z, Akkam M, Sleilaty F. Risk factors for postthyroidectomy hypocalcemia. J Am Coll Surg. 2002 Oct;195(4):456-61. doi: 10.1016/s1072-7515(02)01310-8. PMID 12375749
- BACKGROUNDMathur A, Nagarajan N, Kahan S, Schneider EB, Zeiger MA. Association of Parathyroid Hormone Level With Postthyroidectomy Hypocalcemia: A Systematic Review. JAMA Surg. 2018 Jan 1;153(1):69-76. doi: 10.1001/jamasurg.2017.3398. PMID 29167863
- BACKGROUNDTerris DJ, Snyder S, Carneiro-Pla D, Inabnet WB 3rd, Kandil E, Orloff L, Shindo M, Tufano RP, Tuttle RM, Urken M, Yeh MW; American Thyroid Association Surgical Affairs Committee Writing Task Force. American Thyroid Association statement on outpatient thyroidectomy. Thyroid. 2013 Oct;23(10):1193-202. doi: 10.1089/thy.2013.0049. Epub 2013 Sep 14. PMID 23742254
- BACKGROUNDDedivitis RA, Aires FT, Cernea CR. Hypoparathyroidism after thyroidectomy: prevention, assessment and management. Curr Opin Otolaryngol Head Neck Surg. 2017 Apr;25(2):142-146. doi: 10.1097/MOO.0000000000000346. PMID 28267706
- BACKGROUNDSanabria A, Dominguez LC, Vega V, Osorio C, Duarte D. Routine postoperative administration of vitamin D and calcium after total thyroidectomy: a meta-analysis. Int J Surg. 2011;9(1):46-51. doi: 10.1016/j.ijsu.2010.08.006. Epub 2010 Sep 8. PMID 20804871
- BACKGROUNDIglesias P, Diez JJ. Endocrine Complications of Surgical Treatment of Thyroid Cancer: An Update. Exp Clin Endocrinol Diabetes. 2017 Sep;125(8):497-505. doi: 10.1055/s-0043-106441. Epub 2017 Apr 25. PMID 28444664
- BACKGROUNDLeoncini E, Ricciardi W, Cadoni G, Arzani D, Petrelli L, Paludetti G, Brennan P, Luce D, Stucker I, Matsuo K, Talamini R, La Vecchia C, Olshan AF, Winn DM, Herrero R, Franceschi S, Castellsague X, Muscat J, Morgenstern H, Zhang ZF, Levi F, Dal Maso L, Kelsey K, McClean M, Vaughan TL, Lazarus P, Purdue MP, Hayes RB, Chen C, Schwartz SM, Shangina O, Koifman S, Ahrens W, Matos E, Lagiou P, Lissowska J, Szeszenia-Dabrowska N, Fernandez L, Menezes A, Agudo A, Daudt AW, Richiardi L, Kjaerheim K, Mates D, Betka J, Yu GP, Schantz S, Simonato L, Brenner H, Conway DI, Macfarlane TV, Thomson P, Fabianova E, Znaor A, Rudnai P, Healy C, Boffetta P, Chuang SC, Lee YC, Hashibe M, Boccia S. Adult height and head and neck cancer: a pooled analysis within the INHANCE Consortium. Eur J Epidemiol. 2014 Jan;29(1):35-48. doi: 10.1007/s10654-013-9863-2. Epub 2013 Nov 24.