Prevention of Hypocalcemia in Patients Undergoing Total Thyroidectomy Plus Central Neck Dissection

Phase 2

Completed

• Conditions: Hypocalcemia

• Registration Number: NCT00630214
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2008-02
• Study First Submitted: 2008-02-25
• Study First Submitted QC: 2008-03-05
• Last Update Submitted: 2008-03-05
• Study First Posted: 2008-03-06
• Last Update Posted: 2008-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The clinical utility of calcium and vitamin D supplements for prevention of hypocalcemia following total thyroidectomy plus central neck dissection	To postoperative 12 months

Trial Locations

Locations (1)

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of