Prevention of Hypocalcemia in Patients Undergoing Total Thyroidectomy Plus Central Neck Dissection
Information source: Asan Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypocalcemia
Intervention: Oral calcium plus vitamin D (Dietary Supplement); Oral calcium alone (Dietary Supplement)
Phase: Phase 2
Status: Completed
Sponsored by: Asan Medical Center Official(s) and/or principal investigator(s):
Jong-Lyel Roh, MD, PhD, Principal Investigator, Affiliation: Asan Medical Center & Chungnam National University Hospital
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.
Clinical Details
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 design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The clinical utility of calcium and vitamin D supplements for prevention of hypocalcemia following total thyroidectomy plus central neck dissection
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
Minimum age: 15 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Chungnam National University Hospital, Daejeon 301-040, Korea, Republic of
Additional Information
Related publications: 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.
Starting date: May 2004
Ending date: February 2006
Last updated: March 5, 2008
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