Randomized controlled trial of alfacalcidol supplementation for the reduction of hypocalcemia after total thyroidectomy

Background The aim was to assess the effectiveness of routine administration of calcium +/– vitamin D3 compared with a serum calcium level‐based strategy to prevent symptomatic hypocalcaemia after thyroidectomy. Methods RCTs comparing routine supplementation of calcium +/– vitamin D3 with treatment based on serum calcium levels measured after total thyroidectomy, published between 1980 and 2017, were identified in MEDLINE, Embase, LILACS and Google Scholar databases. Risk of bias was evaluated using the Cochrane Collaboration tool. Risk differences were calculated by random‐effects meta‐analysis. Meta‐regression and cumulative meta‐analysis were used to explore the best therapeutic approach. Results Fifteen studies with 3037 patients were included, and seven treatment comparisons were made. Routine supplementation with calcium + vitamin D3 offered a lower risk of symptomatic (risk difference (RD) –0·25, 95 per cent c.i. –0·32 to –0·18) and biochemical (RD –0·24, –0·31 to –0·17) hypocalcaemia than treatment based on measurement of calcium levels. The number needed to treat was 4 (95 per cent c.i. 3 to 6) for symptomatic hypocalcaemia. No publication bias was found; although heterogeneity was high for some comparisons, sensitivity analysis did not change the main results. Conclusion Routine postoperative administration of calcium + vitamin D3 is effective in decreasing the rate of symptomatic and biochemical hypocalcaemia.

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“…The primary search identified 1010 articles. Only 15 of 30 full‐text articles assessed satisfied the inclusion criteria ( Fig . ).…”

Section: Resultsmentioning

confidence: 99%

Meta-analysis of routine calcium/vitamin D3 supplementationversusserum calcium level-based strategy to prevent postoperative hypocalcaemia after thyroidectomy

Sanábria

Rojas

Arevalo

2019

British Journal of Surgery

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“…Furthermore, being able to identify higher risk patients may allow precautions to be made to prevent or limit the consequences. There is some evidence that preoperative vitamin D deficiency is associated with postoperative hypocalcaemia and preloading with vitamin D is advocated by some authors [15,16,[23][24][25]. Hypomagnesaemia may also be a reversible factor that impacts on perioperative serum calcium levels [15].…”

Section: Clinical Applicationmentioning

confidence: 99%

Better consenting for thyroidectomy: who has an increased risk of postoperative hypocalcaemia?

Harris

Prades

Ткачук

et al. 2016

Eur Arch Otorhinolaryngol

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Hypocalcaemia is the most common complication following thyroidectomy. This study aimed to establish the factors associated with increased risk of hypocalcaemia on day 1 following thyroidectomy. All patients who underwent thyroidectomy under a single consultant during a 5-year period were included. A multivariate analysis was undertaken to ascertain which variables had the most effect on the risk of hypocalcaemia. A prognosis table was constructed to allow risk to be predicted for individual patients based on these factors. Included in the analysis were 210 procedures and 194 patients. Eighty-two percent of patients had no calcium derangement postoperatively. Fourteen point nine percent were categorised as early hypocalcaemia, 1 % had protracted hypocalcaemia and 2.1 % had permanent hypocalcaemia. For hemi-thyroidectomies 2.8 % had postoperative hypocalcaemia and 0.9 % had permanent hypocalcaemia. The multivariate analysis revealed total thyroidectomy (risk ratio 26.5, p < 0.0001), diabetes (risk ratio 4.8, p = 0.07) and thyrotoxicosis (risk ratio 3.1, p = 0.04) as statistically significant variables for early postoperative hypocalcaemia. Gender as an isolated factor did not reach significance but was included in the model. The p value for the model was p < 1 × 10. Total thyroidectomy increases risk of early hypocalcaemia when compared to hemithyroidectomy. Gender, diabetes and thyrotoxicosis were also been found to influence the risk. All of these factors are available pre-operatively and can therefore be used to predict a more specific risk for individual patients. It is hoped that this can lead to better informed consent, prevention and better resource allocation.

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“…Baseline vitamin D status was not reported. Genser and colleagues randomized 222 French patients to either placebo or 2 µg alfacalcidol for 9 days, beginning one day prior to surgery. The primary end‐point (postoperative calcium <2.0 mmol/L) occurred in 37% of placebo‐treated participants compared to 30% of alfacalcidol‐treated participants ( P = 0.25), overall rates that were similar to this present study.…”

Section: Discussionmentioning

confidence: 99%

“…Previously, two prospective randomized trials have shown that treatment with activated vitamin D reduces incidence of postoperative hypocalcaemia . However, due to its potency, activated vitamin D presents a risk of hypercalcaemia, which may preclude widespread adoption.…”

Section: Introductionmentioning

confidence: 99%

High‐dose preoperative cholecalciferol to prevent post‐thyroidectomy hypocalcaemia: A randomized, double‐blinded placebo‐controlled trial

Rowe

Arthurs

OʼNeill

et al. 2018

Clinical Endocrinology

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Summary 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.

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Randomized controlled trial of alfacalcidol supplementation for the reduction of hypocalcemia after total thyroidectomy

Cited by 40 publications

References 27 publications

Meta-analysis of routine calcium/vitamin D3 supplementationversusserum calcium level-based strategy to prevent postoperative hypocalcaemia after thyroidectomy

Meta-analysis of routine calcium/vitamin D3 supplementationversusserum calcium level-based strategy to prevent postoperative hypocalcaemia after thyroidectomy

Better consenting for thyroidectomy: who has an increased risk of postoperative hypocalcaemia?

High‐dose preoperative cholecalciferol to prevent post‐thyroidectomy hypocalcaemia: A randomized, double‐blinded placebo‐controlled trial

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