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

Hypocalcemia Clinical Trial

Official title:

Phase 2 Study of Routine Oral Calcium and Vitamine D Supplements to Prevent Hypocalcemia After Total Thyroidectomy in Papillary Thyroid Carcinoma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630214
• Other study ID #: 2004-03-01
• Status: Completed
• Phase: Phase 2
• First received: February 25, 2008
• Last updated: March 5, 2008
• Start date: May 2004
• Est. completion date: February 2006

Study information

• Verified date: February 2008
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypocalcemia

Intervention

Dietary Supplement:
• Oral calcium plus vitamin D
calcium supplementation took 3 g/day oral calcium (1 g every 8 h) plus 1 mcg/day vitamin D (0.5 mcg every 12 h), beginning on the night of surgery and continuing for 14 days.
• Oral calcium alone
calcium carbonate (3 g/day, 1 g every 8 h)

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Daejeon

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Chungnam National University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The clinical utility of calcium and vitamin D supplements for prevention of hypocalcemia following total thyroidectomy plus central neck dissection		To postoperative 12 months	Yes