Prevention of Hypocalcemia in Patients Undergoing Total Thyroidectomy Plus Central Neck Dissection
NCT ID: NCT00630214
Last Updated: 2008-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2004-05-31
2006-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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C
No supplements after total thyroidectomy and central neck dissection
No interventions assigned to this group
D
No central neck dissection group (total thyroidectomy alone)
No interventions assigned to this group
A
Oral calcium plus vitamin D supplements after total thyroidectomy and central neck dissection
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.
B
Oral calcium alone supplement after total thyroidectomy and central neck dissection
Oral calcium alone
calcium carbonate (3 g/day, 1 g every 8 h)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing total thyroidectomy plus central neck dissection
Exclusion Criteria
* Patients with parathyroid diseases
* Other thyroid malignancies
* Early loss of follow-up without proper evaluation of postoperative serum calcium levels and symptoms
15 Years
85 Years
ALL
No
Sponsors
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Chungnam National University
OTHER
Asan Medical Center
OTHER
Responsible Party
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Chungnam National University Hospital & Asan Medical Center
Principal Investigators
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Jong-Lyel Roh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center & Chungnam National University Hospital
Locations
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Chungnam National University Hospital
Daejeon, , South Korea
Countries
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References
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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.
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.
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.
Other Identifiers
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2004-03-01
Identifier Type: -
Identifier Source: org_study_id
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