- Title
- High-dose preoperative cholecalciferol to prevent post-thyroidectomy hypocalcaemia: A randomized, double-blinded placebo-controlled trial
- Creator
- Rowe, Christopher W.; Arthurs, Sam; O'Neill, Christine J.; Hawthorne, Jacqueline; Carroll, Rosemary; Wynne, Katie; Bendinelli, Cino
- Relation
- Clinical Endocrinology Vol. 90, Issue 2, p. 343-350
- Publisher Link
- http://dx.doi.org/10.1111/cen.13897
- Publisher
- Wiley-Blackwell Publishing
- Resource Type
- journal article
- Date
- 2019
- Description
- Objective: Post‐thyroidectomy hypocalcaemia is a significant cause of morbidity and prolonged hospitalization, usually due to transient parathyroid gland damage, treated with calcium and vitamin D supplementation. We present a randomized, double‐blinded placebo‐controlled trial of preoperative loading with high‐dose cholecalciferol (300 000 IU) to reduce post‐thyroidectomy hypocalcaemia. Patients and Measurements: Patients (n = 160) presenting for thyroidectomy at tertiary hospitals were randomized 1:1 to cholecalciferol (300 000 IU) or placebo 7 days prior to thyroidectomy. Ten patients withdrew prior to surgery. The primary outcome was post‐operative hypocalcaemia (corrected calcium <2.1 mmol/L in first 180 days). Results: The study included 150 patients undergoing thyroidectomy for Graves’ disease (31%), malignancy (20%) and goitre (49%). Mean pre‐enrolment vitamin D was 72 ± 26 nmol/L. Postoperative hypocalcaemia occurred in 21/72 (29%) assigned to cholecalciferol and 30/78 (38%) participants assigned to placebo (P = 0.23). There were no differences in secondary end‐points between groups. In pre‐specified stratification, baseline vitamin D status did not predict hypocalcaemia, although most individuals were vitamin D replete at baseline. Post‐hoc stratification by day 1 parathyroid hormone (PTH) (<10 pg/mL, low vs ≥10 pg/mL, normal) was explored due to highly divergent rates of hypocalcaemia in these groups. Using a Cox regression model, the hazard ratio for hypocalcaemia in the cholecalciferol group was 0.56 (95%CI 0.32‐0.98, P = 0.04) after stratification for Day 1 PTH. Further clinical benefits were observed in these subgroups. Conclusions: Pre‐thyroidectomy treatment with high‐dose cholecalciferol did not reduce the overall rate of hypocalcaemia following thyroidectomy. In subgroups stratified by day 1 PTH status, improved clinical outcomes were noted.
- Subject
- cholecalciferol; hypocalcaemia; RCT; thyroidectomy; vitamin D
- Identifier
- http://hdl.handle.net/1959.13/1413602
- Identifier
- uon:36646
- Identifier
- ISSN:0300-0664
- Language
- eng
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