Clinical trial NCT00630214: Prevention of Hypocalcemia in Patients Undergoing Total Thyroidectomy Plus Central Neck Dissection
Official title: Phase 2 Study of Routine Oral Calcium and Vitamine D Supplements to Prevent Hypocalcemia After Total Thyroidectomy in Papillary Thyroid Carcinoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypocalcemia
Keywords: Total thyroidectomy
CND
hypocalcemia
calcium
vitamin D
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Chungnam National University
First posted: 2008-03-06
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The clinical utility of calcium and vitamin D supplements for prevention of hypocalcemia following total thyroidectomy plus central neck dissection
timeFrame: To postoperative 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
affiliation: Asan Medical Center & Chungnam National University Hospital
name: Jong-Lyel Roh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bellantone R, Lombardi CP, Raffaelli M, Boscherini M, Alesina PF, De Crea C, Traini E, Princi P. Is routine supplementation therapy (calcium and vitamin D) useful after total thyroidectomy? Surgery. 2002 Dec;132(6):1109-12; discussion 1112-3. doi: 10.1067/msy.2002.128617.
citation: Moore FD Jr. Oral calcium supplements to enhance early hospital discharge after bilateral surgical treatment of the thyroid gland or exploration of the parathyroid glands. J Am Coll Surg. 1994 Jan;178(1):11-6.
citation: Roh JL, Park JY, Park CI. Prevention of postoperative hypocalcemia with routine oral calcium and vitamin D supplements in patients with differentiated papillary thyroid carcinoma undergoing total thyroidectomy plus central neck dissection. Cancer. 2009 Jan 15;115(2):251-8. doi: 10.1002/cncr.24027.