Vitamin D Levels and Postoperative Hypocalcemia After Total Thyroidectomy

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ClinicalTrials.gov Identifier: NCT01039714

Recruitment Status : Unknown

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

First Posted : December 25, 2009

Last Update Posted : December 25, 2009

Sponsor:

Information provided by:

Aristotle University Of Thessaloniki

Study Description

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.

Condition or disease
Hypocalcemia Hypoparathyroidism Vitamin D Deficiency Thyroidectomy

Study Design


Study Type :	Observational
Estimated Enrollment :	200 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Preoperative Vitamin D Levels as a Prognostic Factor for Postoperative Hypocalcemia and Hypoparathyroidism After Total Thyroidectomy
Study Start Date :	December 2009
Estimated Primary Completion Date :	April 2010
Estimated Study Completion Date :	May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Drug Information available for: Vitamin D

Genetic and Rare Diseases Information Center resources: Hypoparathyroidism

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Total Thyroidectomy

Outcome Measures

Primary Outcome Measures :

Impact of preoperative vitamin D levels on postoperative hypocalcemia after total thyroidectomy. [ Time Frame: 24 hours postoperatively ]

Secondary Outcome Measures :

Impact of preoperative vitamin D levels on parathyroid function after total thyroidectomy. [ Time Frame: 24 hours postoperatively ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted:	December 25, 2009 Key Record Dates
Last Update Posted:	December 25, 2009
Last Verified:	December 2009

Keywords provided by Aristotle University Of Thessaloniki:


Hypocalcemia Hypoparathyroidism Vitamin D deficiency	Total thyroidectomy calcium PTH

Additional relevant MeSH terms:


Vitamin D Deficiency Hypoparathyroidism Hypocalcemia Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Parathyroid Diseases Endocrine System Diseases Calcium Metabolism Disorders	Metabolic Diseases Water-Electrolyte Imbalance Vitamins Vitamin D Ergocalciferols Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents

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