Routine Calcium for Preventing Hypocalcemia

Not Applicable

Completed

• Conditions: Thyroid Neoplasm
• Interventions: Drug: Calcium Carbonate 1500 Mg with Vitamin D

• Registration Number: NCT03484416
• Lead Sponsor: Ewha Womans University Mokdong Hospital

Brief Summary

The present study investigated the effect of routine calcium and vitamin D supplementation and tried to find the predictors for postoperative hypocalcemia in patients with thyroid cancer.

Detailed Description

The present study investigated the effect of routine calcium and vitamin D supplementation and tried to find the predictors for postoperative hypocalcemia in patients with thyroid cancer. Demographic data, including age, sex, pathologic features, and postoperative laboratory test results were analyzed, as was the development of symptomatic hypocalcemia, defined as an ionized calcium concentration below 4.6 mg/dL (normal range, 4.6-5.4 mg/dL) associated with hypocalcemic symptoms. Hypocalcemia was considered permanent in patients who required calcium supplementation for longer than 6 months after thyroidectomy.

Serum concentrations of PTH and ionized calcium were measured 1 and 14 days postoperatively. Patients in the routine calcium group received oral supplements of 1,500 mg/day elemental calcium and 1,000 IU/day cholecalciferol for 2 weeks, beginning on the first postoperative day (POD) to the 14th POD, whereas patients in the control group received no supplementation. If symptomatic hypocalcemia developed, patients in both groups received 2.0 g of intravenous calcium, followed by oral supplementation with 3,000-4,000 mg/day elemental calcium and 1,000-2,000 IU/day cholecalciferol up to the 14th POD. If hypocalcemic symptoms were persistent or worsening 2 hours after calcium administration, patients were administered another intravenous calcium supplementation.

Study Timeline

• Study Start: 2016-03-01
• Primary Completion: 2017-05-30
• Study Completion: 2017-05-30
• Status Verified: 2018-03
• Study First Submitted: 2018-03-25
• Study First Submitted QC: 2018-03-29
• Last Update Submitted: 2018-03-29
• Study First Posted: 2018-03-30
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• patients with thyroid cancer
• euthyroid state
• underwent total thyroidectomy

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Exclusion Criteria

• previous history of neck surgery or irradiation
• calcium supplement before enrollment
• hyperthyroidism or hypothyroidism
• pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine calcium	Calcium Carbonate 1500 Mg with Vitamin D	Patients in the routine calcium group received oral supplements of 1,500 mg/day elemental calcium (by calcium carbonate) and 1,000 IU/day cholecalciferol for 2 weeks, beginning on the first postoperative day

Primary Outcome Measures

Name	Time	Method
symptomatic hypocalcemia	postoperative day 1	Symptomatic hypocalcemia was defined as an ionized calcium concentration below 4.6 mg/dL (normal range, 4.6-5.4 mg/dL) associated with hypocalcemic symptoms.
permanent hypocalcemia	postoperative 6 months	Symptomatic hypocalcemia was defined as an ionized calcium concentration below 4.6 mg/dL (normal range, 4.6-5.4 mg/dL) associated with hypocalcemic symptoms.

Trial Locations

Locations (1)

Ewha Womans University Medical Center; 🇰🇷 Seoul, Korea, Republic of