Routine Calcium for Preventing Hypocalcemia

Thyroid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03484416
• Other study ID #: Rouine Calcium
• Status: Completed
• Phase: N/A
• First received: March 25, 2018
• Last updated: March 29, 2018
• Start date: March 1, 2016
• Est. completion date: May 30, 2017

Study information

• Verified date: March 2018
• Source: Ewha Womans University Mokdong Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: May 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypocalcemia
• Thyroid Neoplasm
• Thyroid Neoplasms

Intervention

Drug:
• Calcium Carbonate 1500 Mg with Vitamin D
Patients in the routine calcium group received oral supplements of 1,500 mg/day elemental calcium and 1,000 IU/day cholecalciferol (Dicamax 1000) for 2 weeks, whereas control group did not

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University Mokdong Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptomatic hypocalcemia	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.	postoperative day 1
Primary	permanent hypocalcemia	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.	postoperative 6 months