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

Primary Purpose

Hypocalcemia

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Oral calcium plus vitamin D

Oral calcium alone

About this trial

This is an interventional prevention trial for Hypocalcemia focused on measuring Total thyroidectomy, CND, hypocalcemia, calcium, vitamin D

Eligibility Criteria

15 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chungnam National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Arm Label

Arm Description

No supplements after total thyroidectomy and central neck dissection

No central neck dissection group (total thyroidectomy alone)

Oral calcium plus vitamin D supplements after total thyroidectomy and central neck dissection

Oral calcium alone supplement after total thyroidectomy and central neck dissection

Outcomes

Primary Outcome Measures

The clinical utility of calcium and vitamin D supplements for prevention of hypocalcemia following total thyroidectomy plus central neck dissection

Secondary Outcome Measures

Full Information

NCT ID

NCT00630214

First Posted

February 25, 2008

Last Updated

March 5, 2008

Sponsor

Asan Medical Center

Collaborators

Chungnam National University

1. Study Identification

Unique Protocol Identification Number

NCT00630214

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2008

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

February 2006 (Actual)

Study Completion Date

February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Asan Medical Center

Collaborators

Chungnam National University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypocalcemia

Keywords

Total thyroidectomy, CND, hypocalcemia, calcium, vitamin D

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Description

No supplements after total thyroidectomy and central neck dissection

Arm Title

Arm Type

No Intervention

Arm Description

No central neck dissection group (total thyroidectomy alone)

Arm Title

Arm Type

Active Comparator

Arm Description

Oral calcium plus vitamin D supplements after total thyroidectomy and central neck dissection

Arm Title

Arm Type

Active Comparator

Arm Description

Oral calcium alone supplement after total thyroidectomy and central neck dissection

Intervention Type

Dietary Supplement

Intervention Name(s)

Oral calcium plus vitamin D

Other Intervention Name(s)

calcium carbonate and one-alpha (vitamin D)

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Oral calcium alone

Other Intervention Name(s)

calcium carbonate (Korea United Pharmaceutical Co, Seoul, Korea)

Intervention Description

calcium carbonate (3 g/day, 1 g every 8 h)

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jong-Lyel Roh, MD, PhD

Organizational Affiliation

Asan Medical Center & Chungnam National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chungnam National University Hospital

City

Daejeon

ZIP/Postal Code

301-040

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

12490862

Citation

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.

Results Reference

background

PubMed Identifier

8156110

Citation

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.

Results Reference

result

PubMed Identifier

19117033

Citation

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.

Results Reference

derived

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

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