Vitamin D Levels and Postoperative Hypocalcemia After Tot... | NCT01039714

Studies
Vitamin D Levels and Postoperative Hypocalcemia After Total Thyroidectomy

NCT01039714

Sponsor

Aristotle University Of Thessaloniki

Status

Unknown status

Last Update Posted

Dec 25, 2009Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Hypocalcemia
Hypoparathyroidism
Vitamin D Deficiency
Thyroidectomy

Interventions

Not provided

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Apr 2010Estimated

Completion Date

May 2010Estimated

First Submitted Date

Sep 29, 2009

First Submission Date that Met QC Criteria

Dec 24, 2009

First Posted Date

Dec 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2009

Last Update Posted Date

Dec 25, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hypocalcemia is one of the most frequent complications of total thyroidectomy, a procedure used for benign as well as malignant conditions of the thyroid gland. Postoperative hypocalcemia is usually caused by hypoparathyroidism. Vitamin D is implicated in calcium metabolism as it increases intestinal calcium transport and regulates parathormone production. Aim of the present study is to evaluate preoperative vitamin D levels as a prognostic factor for postoperative hypocalcemia and hypoparathyroidism.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
Total Thyroidectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Impact of preoperative vitamin D levels on postoperative hypocalcemia after total thyroidectomy.		24 hours postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Impact of preoperative vitamin D levels on parathyroid function after total thyroidectomy.		24 hours postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is over 18 years old
Patient scheduled for total thyroidectomy
Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures

Exclusion Criteria:

Primary hyperparathyroidism
Primary hypoparathyroidism
Chronic Renal Failure
Hypoalbuminemia
Neck irradiation
Systematic Diseases (e.g., infections)
Thyroid or parathyroid cancer
Osteoporosis
Drugs that influence calcium metabolism (vitamin D analogues, oral calcium supplements, biphosphonates, teriparatide, thiazide diuretics)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients subjected to total thyroidectomy in Third Surgical Clinic of AHEPA University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Theodossis S Papavramidis, MD, PhD	Contact	00302310993197		papavramidis@hotmail.com
Olympia E Anastasiou, MD	Contact	00302310993197		olympia_anastasiou@yahoo.com

Overall Officials

Name	Affiliation	Role
Spyros T Papavramidis, Prof	Aristotle University Of Thessaloniki	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AHEPA University Hospital Thessaloniki, Greece	Recruiting	Thessaloniki	Makedonia		Greece

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19324110	Background	Erbil Y, Barbaros U, Temel B, Turkoglu U, Issever H, Bozbora A, Ozarmagan S, Tezelman S. The impact of age, vitamin D(3) level, and incidental parathyroidectomy on postoperative hypocalcemia after total or near total thyroidectomy. Am J Surg. 2009 Apr;197(4):439-46. doi: 10.1016/j.amjsurg.2008.01.032.

ID	Term
D002128	Calcium Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D014883	Water-Electrolyte Imbalance

ID	Term
D006996	Hypocalcemia
D007011	Hypoparathyroidism
D014808	Vitamin D Deficiency