Routine Low-dose Calcium and Vitamin D Supplementation for Preventing Symptomatic Postthyroidectomy Hypocalcemia
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
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
Hyungju Kwon
Assistant Professor
Ewha Womans University Mokdong Hospital
