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

NCT ID: NCT00630214

Last Updated: 2008-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2006-02-28

Brief Summary

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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

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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.

Conditions

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Hypocalcemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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C

No supplements after total thyroidectomy and central neck dissection

Group Type NO_INTERVENTION

No interventions assigned to this group

D

No central neck dissection group (total thyroidectomy alone)

Group Type NO_INTERVENTION

No interventions assigned to this group

A

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

Group Type ACTIVE_COMPARATOR

Oral calcium plus vitamin D

Intervention Type DIETARY_SUPPLEMENT

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

Oral calcium alone supplement after total thyroidectomy and central neck dissection

Group Type ACTIVE_COMPARATOR

Oral calcium alone

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Oral calcium alone

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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calcium carbonate and one-alpha (vitamin D) calcium carbonate (Korea United Pharmaceutical Co, Seoul, Korea)

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chungnam National University

OTHER

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Chungnam National University Hospital & Asan Medical Center

Principal Investigators

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Jong-Lyel Roh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center & Chungnam National University Hospital

Locations

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Chungnam National University Hospital

Daejeon, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 12490862 (View on PubMed)

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.

Reference Type RESULT
PMID: 8156110 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19117033 (View on PubMed)

Other Identifiers

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2004-03-01

Identifier Type: -

Identifier Source: org_study_id

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