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

Asan Medical Center

Status and phase: Completed; Phase 2

Conditions: Hypocalcemia

Treatments: Dietary Supplement: Oral calcium alone; Dietary Supplement: Oral calcium plus vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT00630214

2004-03-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 15 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups

C

No Intervention group

Description:

No supplements after total thyroidectomy and central neck dissection

D

No Intervention group

Description:

No central neck dissection group (total thyroidectomy alone)

A

Active Comparator group

Description:

Oral calcium plus vitamin D supplements after total thyroidectomy and central neck dissection

Treatment:

Dietary Supplement: Oral calcium plus vitamin D

B

Active Comparator group

Description:

Oral calcium alone supplement after total thyroidectomy and central neck dissection

Treatment:

Dietary Supplement: Oral calcium alone