David C Shonka1, Anne K Maxwell2, Gina R Petroni3, Mark J Jameson1. 1. Department of Otolaryngology-Head and Neck Surgery, University of Virginia Health System, Charlottesville, Virginia, USA. 2. University of Virginia School of Medicine, University of Virginia Health System, Charlottesville, Virginia, USA. 3. Department of Public Health Sciences, University of Virginia Health System, Charlottesville, Virginia, USA.
Abstract
BACKGROUND: A prospective, stratified, randomized, double-blind, placebo-controlled study was conducted to observe the impact of preoperative calcitriol supplementation on serum calcium levels following total thyroidectomy. METHODS: Subjects were randomized 1:1 to receive 1 μg calcitriol or placebo for 1 week preceding thyroidectomy. The primary outcome measure was change in serum calcium from baseline to 18 h post-thyroidectomy. Subjects were also assessed for incidence of symptomatic hypocalcemia, length of stay, readmission for hypocalcemia, and intravenous calcium supplementation. RESULTS:Forty-seven patients underwentthyroidectomy; 23 received preoperative calcitriol supplementation, and 24 received placebo. Repeated measures regression demonstrated no difference in postoperative serum calcium over time (p = 0.22). There were no occurrences of hypocalcemia, intravenous calcium supplementation, or readmission in either group. No difference was observed in length of stay (p = 0.38). One patient in the calcitriol group developed Grade 3 hypercalcemia. CONCLUSIONS:Preoperative calcitriol supplementation had no impact on postoperative serum calcium levels compared to placebo.
RCT Entities:
BACKGROUND: A prospective, stratified, randomized, double-blind, placebo-controlled study was conducted to observe the impact of preoperative calcitriol supplementation on serum calcium levels following total thyroidectomy. METHODS: Subjects were randomized 1:1 to receive 1 μg calcitriol or placebo for 1 week preceding thyroidectomy. The primary outcome measure was change in serum calcium from baseline to 18 h post-thyroidectomy. Subjects were also assessed for incidence of symptomatic hypocalcemia, length of stay, readmission for hypocalcemia, and intravenous calcium supplementation. RESULTS: Forty-seven patients underwent thyroidectomy; 23 received preoperative calcitriol supplementation, and 24 received placebo. Repeated measures regression demonstrated no difference in postoperative serum calcium over time (p = 0.22). There were no occurrences of hypocalcemia, intravenous calcium supplementation, or readmission in either group. No difference was observed in length of stay (p = 0.38). One patient in the calcitriol group developed Grade 3 hypercalcemia. CONCLUSIONS: Preoperative calcitriol supplementation had no impact on postoperative serum calcium levels compared to placebo.