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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00630214
Other study ID # 2004-03-01
Secondary ID
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


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
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