Phase 2 Study of Routine Oral Calcium and Vitamine D Supplements to Prevent Hypocalcemia After Total Thyroidectomy in Papillary Thyroid Carcinoma Patients
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Hypocalcemia
- Sponsor
- Asan Medical Center
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- The clinical utility of calcium and vitamin D supplements for prevention of hypocalcemia following total thyroidectomy plus central neck dissection
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
the increased risk of hypocalcemia following total thyroidectomy plus central neck dissection can be minimized by routine administration of oral calcium and vitamin D supplements during the early postoperative period.
Detailed Description
Of patients with differentiated papillary thyroid carcinoma, group D underwent total thyroidectomy alone and groups A-C underwent total thyroidectomy plus CND. The latter were randomized to oral calcium (3 g/day) plus vitamin D (1 mcg/day) (group A, n = 49), calcium alone (group B, n = 49), or no supplements (group C, n = 50). Hypocalcemic symptoms, serum calcium, and parathyroid hormone (PTH) levels were compared among the groups.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Differentiated papillary thyroid carcinoma
- •Undergoing total thyroidectomy plus central neck dissection
Exclusion Criteria
- •Previous thyroid or neck surgery
- •Patients with parathyroid diseases
- •Other thyroid malignancies
- •Early loss of follow-up without proper evaluation of postoperative serum calcium levels and symptoms
Outcomes
Primary Outcomes
The clinical utility of calcium and vitamin D supplements for prevention of hypocalcemia following total thyroidectomy plus central neck dissection
Time Frame: To postoperative 12 months