Routine Calcium for Preventing Hypocalcemia

Ewha Womans University

Status: Completed

Conditions: Thyroid Neoplasm

Treatments: Drug: Calcium Carbonate 1500 Mg with Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT03484416

Rouine Calcium

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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138 participants in 2 patient groups

Routine calcium

Active Comparator group

Description:

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

Treatment:

Drug: Calcium Carbonate 1500 Mg with Vitamin D

control

No Intervention group

Description:

Patients in the control group did not receive calcium or cholecalciferol for 2 weeks