Prevention of Hypocalcemia in Patients Undergoing Total Thyroidectomy Plus Central Neck Dissection - Full Text View

Sponsors and Collaborators:	Asan Medical Center Chungnam National University
Information provided by:	Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00630214

Purpose

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.

Condition	Intervention	Phase
Hypocalcemia	Dietary Supplement: Oral calcium plus vitamin D Dietary Supplement: Oral calcium alone	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 2 Study of Routine Oral Calcium and Vitamine D Supplements to Prevent Hypocalcemia After Total Thyroidectomy in Papillary Thyroid Carcinoma Patients

Resource links provided by NLM:

MedlinePlus related topics: Calcium Dietary Supplements Diets

Drug Information available for: Calcium gluconate Calcium carbonate Vitamin D

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:

The clinical utility of calcium and vitamin D supplements for prevention of hypocalcemia following total thyroidectomy plus central neck dissection [ Time Frame: To postoperative 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	200
Study Start Date:	May 2004
Study Completion Date:	February 2006
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
C: No Intervention No supplements after total thyroidectomy and central neck dissection
D: No Intervention No central neck dissection group (total thyroidectomy alone)
A: Active Comparator Oral calcium plus vitamin D supplements after total thyroidectomy and central neck dissection	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.
B: Active Comparator Oral calcium alone supplement after total thyroidectomy and central neck dissection	Dietary Supplement: Oral calcium alone calcium carbonate (3 g/day, 1 g every 8 h)

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

Ages Eligible for Study:	15 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630214

Locations

Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of, 301-040

Sponsors and Collaborators

Asan Medical Center

Chungnam National University

Investigators

Principal Investigator:

Jong-Lyel Roh, MD, PhD

Asan Medical Center & Chungnam National University Hospital

More Information

Publications:

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.

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Chungnam National University Hospital & Asan Medical Center ( Jong-Lyel Roh, MD, PhD )
Study ID Numbers:	2004-03-01
Study First Received:	February 25, 2008
Last Updated:	March 5, 2008
ClinicalTrials.gov Identifier:	NCT00630214 History of Changes
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Asan Medical Center:

Total thyroidectomy
CND
hypocalcemia
calcium
vitamin D

Study placed in the following topic categories:

Thyroid Cancer, Papillary
1-hydroxycholecalciferol
Tocopherol
Bone Density Conservation Agents
Calcium Carbonate
Tocopherols
Tocotrienol
Vitamins
Tocotrienols
Water-Electrolyte Imbalance
Micronutrients
Metabolic Disorder
Tocopherol acetate
Hypocalcemia

Metabolic Diseases
Thyroid Neoplasms
Ergocalciferol
Ergocalciferols
Trace Elements
Hydroxycholecalciferols
Alpha-Tocopherol
Carcinoma
Calcium, Dietary
Vitamin E
Vitamin D
Vitamin D2
Antacids
Calciferol

Additional relevant MeSH terms:

Hypocalcemia
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Ergocalciferols
Bone Density Conservation Agents
Calcium Carbonate

Pharmacologic Actions
Calcium Metabolism Disorders
Calcium, Dietary
Vitamin D
Vitamins
Water-Electrolyte Imbalance
Antacids
Micronutrients

ClinicalTrials.gov processed this record on July 02, 2009