Routine Calcium for Preventing Hypocalcemia
Primary Purpose
Thyroid Neoplasm
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Calcium Carbonate 1500 Mg with Vitamin D
Sponsored by
About this trial
This is an interventional supportive care trial for Thyroid Neoplasm
Eligibility Criteria
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
Sites / Locations
- Ewha Womans University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Routine calcium
control
Arm 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
Patients in the control group did not receive calcium or cholecalciferol for 2 weeks
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03484416
First Posted
March 25, 2018
Last Updated
March 29, 2018
Sponsor
Ewha Womans University Mokdong Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03484416
Brief Title
Routine Calcium for Preventing Hypocalcemia
Official Title
Routine Low-dose Calcium and Vitamin D Supplementation for Preventing Symptomatic Postthyroidectomy Hypocalcemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
May 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ewha Womans University Mokdong Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Neoplasm
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Routine calcium
Arm Type
Active Comparator
Arm 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
Arm Title
control
Arm Type
No Intervention
Arm Description
Patients in the control group did not receive calcium or cholecalciferol for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Calcium Carbonate 1500 Mg with Vitamin D
Other Intervention Name(s)
Dicamax 1000
Intervention Description
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
Primary Outcome Measure Information:
Title
symptomatic hypocalcemia
Description
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.
Time Frame
postoperative day 1
Title
permanent hypocalcemia
Description
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.
Time Frame
postoperative 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyungju Kwon, MD
Organizational Affiliation
Ewah Womans University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ewha Womans University Medical Center
City
Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Routine Calcium for Preventing Hypocalcemia
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