Calcium+Calcitriol Versus PTH for the Prevention of Hypocalcemia in Thyroidectomy. Randomized Clinical Trial

NCT05252884 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 2

Brief Summary

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

Thyroid Cancer; Goiter; Thyroiditis; Hyperthyroidism

Keywords

thyroidectomy, hypocalcemia, randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• symptomatic hypocalcaemia

  The presence of symptomatic hypocalcaemia in the postoperative period of thyroidectomy defined according to the scale proposed by Wilde et al. (hypoparathyroid patient questionnaire HPQ) Min value 0 Max value 60 Higher scores represent worst symptoms

  15 days

Secondary Outcomes (2)

• Biochemical hypocalcemia

  48 hours and 15 days postoperatively

• Adverse events of the medication

  15 days

Study Arms (2)

calcium correction according to PTH levels

EXPERIMENTAL

A PTH blood test will be performed 4 hours post-thyroidectomy.

Diagnostic Test: calcium correction according to PTH levels

routine postoperative calcium and calcitriol

ACTIVE COMPARATOR

The patient will receive Calcium carbonate + calcitriol

Drug: routine postoperative calcium and calcitriol

Interventions

calcium correction according to PTH levels DIAGNOSTIC_TEST

A PTH blood test will be performed 4 hours post-thyroidectomy. If the PTH result is \>15 pg/mL, the patient will be discharged without calcium intake; if PTH \< 15 pg/mL, start a dose of 1200 mg Calcium carbonate every 8 hours + 0.25 mcg of calcitriol every 12 hours orally for 15 days

Also known as: PTH

calcium correction according to PTH levels

routine postoperative calcium and calcitriol DRUG

The patient will receive a dose of 1,200 mg Calcium carbonate every 8 hours + 0.25 mcg of calcitriol every 12 hours orally for 15 days, starting on the same day as the intervention.

Also known as: calcium carbonate, calcitriol

routine postoperative calcium and calcitriol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Centro de Excelencia en Enfermedades de Cabeza y Cuello: lead
• IPS universitaria: collaborator
• Hospital San Vicente Fundación: collaborator
• Clinica Las Vegas- Grupo QuironSalud: collaborator

Study Sites (2)

Hospital Alma Mater de Antioquia

Medellín, Antioquia, 050010, Colombia

Location

Hospital Universitario San Vicente Fundacion

Medellín, Antioquia, 050010, Colombia

Location

Related Publications (14)

• Abboud 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 BACKGROUND

• Mathur 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 BACKGROUND

• Terris 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 BACKGROUND

• Dedivitis 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 BACKGROUND

• Sanabria 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 BACKGROUND

• Iglesias 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 BACKGROUND

• Leoncini 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.

  PMID: 24271556 BACKGROUND

• Carr AA, Yen TW, Fareau GG, Cayo AK, Misustin SM, Evans DB, Wang TS. A single parathyroid hormone level obtained 4 hours after total thyroidectomy predicts the need for postoperative calcium supplementation. J Am Coll Surg. 2014 Oct;219(4):757-64. doi: 10.1016/j.jamcollsurg.2014.06.003. Epub 2014 Jun 18.

  PMID: 25053220 BACKGROUND

• Arer IM, Kus M, Akkapulu N, Aytac HO, Yabanoglu H, Caliskan K, Tarim MA. Prophylactic oral calcium supplementation therapy to prevent early post thyroidectomy hypocalcemia and evaluation of postoperative parathyroid hormone levels to detect hypocalcemia: A prospective randomized study. Int J Surg. 2017 Feb;38:9-14. doi: 10.1016/j.ijsu.2016.12.041. Epub 2016 Dec 27.

  PMID: 28039060 BACKGROUND

• Sanabria A, Rojas A, Arevalo J. Meta-analysis of routine calcium/vitamin D3 supplementation versus serum calcium level-based strategy to prevent postoperative hypocalcaemia after thyroidectomy. Br J Surg. 2019 Aug;106(9):1126-1137. doi: 10.1002/bjs.11216. Epub 2019 Jun 25.

  PMID: 31236917 BACKGROUND

• Cayo AK, Yen TW, Misustin SM, Wall K, Wilson SD, Evans DB, Wang TS. Predicting the need for calcium and calcitriol supplementation after total thyroidectomy: results of a prospective, randomized study. Surgery. 2012 Dec;152(6):1059-67. doi: 10.1016/j.surg.2012.08.030. Epub 2012 Oct 13.

  PMID: 23068088 BACKGROUND

• Harvey NC, Biver E, Kaufman JM, Bauer J, Branco J, Brandi ML, Bruyere O, Coxam V, Cruz-Jentoft A, Czerwinski E, Dimai H, Fardellone P, Landi F, Reginster JY, Dawson-Hughes B, Kanis JA, Rizzoli R, Cooper C. The role of calcium supplementation in healthy musculoskeletal ageing : An expert consensus meeting of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the International Foundation for Osteoporosis (IOF). Osteoporos Int. 2017 Feb;28(2):447-462. doi: 10.1007/s00198-016-3773-6. Epub 2016 Oct 20.

  PMID: 27761590 BACKGROUND

• Sanaei M, Banasiri M, Shafiee G, Rostami M, Alizad S, Ebrahimi M, Larijani B, Heshmat R. Calcium vitamin D3 supplementation in clinical practice: side effect and satisfaction. J Diabetes Metab Disord. 2016 Mar 29;15:9. doi: 10.1186/s40200-016-0231-0. eCollection 2015.

  PMID: 27030820 BACKGROUND

• Houlton JJ, Pechter W, Steward DL. PACU PTH facilitates safe outpatient total thyroidectomy. Otolaryngol Head Neck Surg. 2011 Jan;144(1):43-7. doi: 10.1177/0194599810390453.

  PMID: 21493385 BACKGROUND

MeSH Terms

Conditions

Thyroid Neoplasms; Goiter; Thyroiditis; Hyperthyroidism; Hypocalcemia

Interventions

Calcitriol; Calcium Carbonate

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Alvaro Sanabria, MD

  Centro de Excelencia en Enfermedades de Cabeza y Cuello

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: It will be randomized by the block method and will be stratified by institution, type of disease (benign vs. malignant) and presence or absence of central voiding. This will be done centrally.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director

Model Details: Randomized, parallel, multicenter stratified clinical trial with 1:1 allocation.

Study Record Dates

• First Submitted: February 13, 2022
• First Posted: February 23, 2022
• Study Start: June 30, 2022
• Primary Completion: October 30, 2024
• Study Completion: December 20, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2)