NCT03484416

Brief Summary

The present study investigated the effect of routine calcium and vitamin D supplementation and tried to find the predictors for postoperative hypocalcemia in patients with thyroid cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

March 25, 2018

Last Update Submit

March 29, 2018

Conditions

Thyroid Neoplasm

Outcome Measures

Primary Outcomes (2)

  • symptomatic hypocalcemia

    Symptomatic hypocalcemia was defined as an ionized calcium concentration below 4.6 mg/dL (normal range, 4.6-5.4 mg/dL) associated with hypocalcemic symptoms.

    postoperative day 1

  • permanent hypocalcemia

    Symptomatic hypocalcemia was defined as an ionized calcium concentration below 4.6 mg/dL (normal range, 4.6-5.4 mg/dL) associated with hypocalcemic symptoms.

    postoperative 6 months

Study Arms (2)

Routine calcium

ACTIVE COMPARATOR

Patients in the routine calcium group received oral supplements of 1,500 mg/day elemental calcium (by calcium carbonate) and 1,000 IU/day cholecalciferol for 2 weeks, beginning on the first postoperative day

Drug: Calcium Carbonate 1500 Mg with Vitamin D

control

NO INTERVENTION

Patients in the control group did not receive calcium or cholecalciferol for 2 weeks

Interventions

Calcium Carbonate 1500 Mg with Vitamin DDRUG

Patients in the routine calcium group received oral supplements of 1,500 mg/day elemental calcium and 1,000 IU/day cholecalciferol (Dicamax 1000) for 2 weeks, whereas control group did not

Also known as: Dicamax 1000
Routine calcium

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with thyroid cancer
  • euthyroid state
  • underwent total thyroidectomy

You may not qualify if:

  • previous history of neck surgery or irradiation
  • calcium supplement before enrollment
  • hyperthyroidism or hypothyroidism
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewha Womans University Medical Center

Seoul, 07985, South Korea

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Calcium CarbonateVitamin D

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMineralsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Hyungju Kwon, MD

    Ewah Womans University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 25, 2018

First Posted

March 30, 2018

Study Start

March 1, 2016

Primary Completion

May 30, 2017

Study Completion

May 30, 2017

Last Updated

March 30, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)