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

This study has been completed.

Sponsor:

Collaborator:

Chungnam National University

Information provided by:

Asan Medical Center

ClinicalTrials.gov Identifier:

NCT00630214

First received: February 25, 2008

Last updated: March 5, 2008

Last verified: February 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

February 25, 2008

Last Updated Date

March 5, 2008

Start Date ^ICMJE

May 2004

Primary Completion Date

February 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00630214 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Hypocalcemia

Intervention ^ICMJE

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.

Other Name: calcium carbonate and one-alpha (vitamin D)
Dietary Supplement: Oral calcium alone
calcium carbonate (3 g/day, 1 g every 8 h)

Other Name: calcium carbonate (Korea United Pharmaceutical Co, Seoul, Korea)

Study Arm (s)

No Intervention: C
No supplements after total thyroidectomy and central neck dissection
No Intervention: D
No central neck dissection group (total thyroidectomy alone)
Active Comparator: A
Oral calcium plus vitamin D supplements after total thyroidectomy and central neck dissection

Intervention: Dietary Supplement: Oral calcium plus vitamin D
Active Comparator: B
Oral calcium alone supplement after total thyroidectomy and central neck dissection

Intervention: Dietary Supplement: Oral calcium alone

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

February 2006

Primary Completion Date

February 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

15 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00630214

Other Study ID Numbers ^ICMJE

2004-03-01

Has Data Monitoring Committee

Yes

Responsible Party

Jong-Lyel Roh, MD, PhD, Chungnam National University Hospital & Asan Medical Center

Study Sponsor ^ICMJE

Asan Medical Center

Collaborators ^ICMJE

Chungnam National University

Investigators ^ICMJE

Principal Investigator:

Jong-Lyel Roh, MD, PhD

Asan Medical Center & Chungnam National University Hospital

Information Provided By

Asan Medical Center

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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