NCT00630214

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
Last Updated

March 6, 2008

Status Verified

February 1, 2008

Enrollment Period

1.8 years

First QC Date

February 25, 2008

Last Update Submit

March 5, 2008

Conditions

Hypocalcemia

Keywords

Total thyroidectomyCNDhypocalcemiacalciumvitamin D

Outcome Measures

Primary Outcomes (1)

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

    To postoperative 12 months

Study Arms (4)

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

B

ACTIVE COMPARATOR

Oral calcium alone supplement after total thyroidectomy and central neck dissection

Dietary Supplement: Oral calcium alone

Interventions

Oral calcium plus vitamin DDIETARY_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.

Also known as: calcium carbonate and one-alpha (vitamin D)
A
Oral calcium aloneDIETARY_SUPPLEMENT

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

Also known as: calcium carbonate (Korea United Pharmaceutical Co, Seoul, Korea)
B

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Differentiated papillary thyroid carcinoma
  • Undergoing total thyroidectomy plus central neck dissection

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam National University Hospital

Daejeon, 301-040, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 12490862BACKGROUND

  • 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.

    PMID: 8156110RESULT

  • 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.

    PMID: 19117033DERIVED

MeSH Terms

Conditions

Hypocalcemia

Interventions

CalciumVitamin DCalcium Carbonatealfacalcidol

Condition Hierarchy (Ancestors)

Calcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological FactorsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCalcium CompoundsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Jong-Lyel Roh, MD, PhD

    Asan Medical Center & Chungnam National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 6, 2008

Study Start

May 1, 2004

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

March 6, 2008

Record last verified: 2008-02

Locations

KR(1)