Vitamin D Levels and Postoperative Hypocalcemia After Total Thyroidectomy

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2009 by Aristotle University Of Thessaloniki.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Aristotle University Of Thessaloniki

ClinicalTrials.gov Identifier:

NCT01039714

First received: September 29, 2009

Last updated: December 24, 2009

Last verified: December 2009

History of Changes

Purpose

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.

Condition
Hypocalcemia Hypoparathyroidism Vitamin D Deficiency Thyroidectomy


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Preoperative Vitamin D Levels as a Prognostic Factor for Postoperative Hypocalcemia and Hypoparathyroidism After Total Thyroidectomy

Resource links provided by NLM:

MedlinePlus related topics: Vitamin D

Drug Information available for: Vitamin D

Genetic and Rare Diseases Information Center resources: Hypoparathyroidism

U.S. FDA Resources

Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:

Impact of preoperative vitamin D levels on postoperative hypocalcemia after total thyroidectomy. [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Impact of preoperative vitamin D levels on parathyroid function after total thyroidectomy. [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]


Estimated Enrollment:	200
Study Start Date:	December 2009
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
Total Thyroidectomy

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039714

Contacts


Contact: Theodossis S Papavramidis, MD, PhD	00302310993197	papavramidis@hotmail.com
Contact: Olympia E Anastasiou, MD	00302310993197	olympia_anastasiou@yahoo.com

Locations


Greece
AHEPA University Hospital Thessaloniki, Greece	Recruiting
Thessaloniki, Makedonia, Greece
Principal Investigator: Theodossis S Papavramidis, MD, PhD
Principal Investigator: Olympia E Anastasiou, MD

Sponsors and Collaborators

Aristotle University Of Thessaloniki

Investigators


Study Director:	Spyros T Papavramidis, Prof	Aristotle University Of Thessaloniki

More Information

Publications:

Erbil Y, Barbaros U, Temel B, Turkoglu U, Işsever H, Bozbora A, Ozarmağan 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.


Responsible Party:	Third Surgical Clinic, AHEPA University Hospital
ClinicalTrials.gov Identifier:	NCT01039714 History of Changes
Other Study ID Numbers:	GXKVITD1
Study First Received:	September 29, 2009
Last Updated:	December 24, 2009
Health Authority:	Greece: Ethics Committee

Keywords provided by Aristotle University Of Thessaloniki:


Hypocalcemia Hypoparathyroidism Vitamin D deficiency	Total thyroidectomy calcium PTH

Additional relevant MeSH terms:


Hypocalcemia Hypoparathyroidism Vitamin D Deficiency Avitaminosis Calcium Metabolism Disorders Deficiency Diseases	Endocrine System Diseases Malnutrition Metabolic Diseases Nutrition Disorders Parathyroid Diseases Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on March 01, 2015

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