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

March 5, 2008 updated by: Asan Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 Names:
  • calcium carbonate and one-alpha (vitamin D)
Active Comparator: B
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)
Other Names:
  • calcium carbonate (Korea United Pharmaceutical Co, Seoul, Korea)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
To postoperative 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Chungnam National University

Investigators

  • Principal Investigator: Jong-Lyel Roh, MD, PhD, Asan Medical Center & Chungnam National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

February 25, 2008

First Submitted That Met QC Criteria

March 5, 2008

First Posted (Estimate)

March 6, 2008

Study Record Updates

Last Update Posted (Estimate)

March 6, 2008

Last Update Submitted That Met QC Criteria

March 5, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-03-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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