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Clinical Trials/NCT03484416
NCT03484416CompletedNot Applicable

Routine Low-dose Calcium and Vitamin D Supplementation for Preventing Symptomatic Postthyroidectomy Hypocalcemia

Ewha Womans University Mokdong Hospital1 site in 1 country138 target enrollmentStarted: March 1, 2016Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
138
Locations
1
Primary Endpoint
symptomatic hypocalcemia

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Routine calcium

Active Comparator

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

Intervention: Calcium Carbonate 1500 Mg with Vitamin D (Drug)

Outcomes

Primary Outcomes

symptomatic hypocalcemia

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hyungju Kwon

Assistant Professor

Ewha Womans University Mokdong Hospital

Study Sites (1)

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