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Vitamin D Levels and Postoperative Hypocalcemia After Total Thyroidectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
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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
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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

Groups and Cohorts
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Group/Cohort
Total Thyroidectomy


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

Secondary Outcome Measures :
  1. 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:

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

Exclusion Criteria:

  1. Primary hyperparathyroidism
  2. Primary hypoparathyroidism
  3. Chronic Renal Failure
  4. Hypoalbuminemia
  5. Neck irradiation
  6. Systematic Diseases (e.g., infections)
  7. Thyroid or parathyroid cancer
  8. Osteoporosis
  9. Drugs that influence calcium metabolism (vitamin D analogues, oral calcium supplements, biphosphonates, teriparatide, thiazide diuretics)
Contacts and Locations
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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
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Contact: Theodossis S Papavramidis, MD, PhD 00302310993197 papavramidis@hotmail.com
Contact: Olympia E Anastasiou, MD 00302310993197 olympia_anastasiou@yahoo.com

Locations
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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
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Study Director: Spyros T Papavramidis, Prof Aristotle University Of Thessaloniki
More Information
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Publications:

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Responsible Party: Third Surgical Clinic, AHEPA University Hospital
ClinicalTrials.gov Identifier: NCT01039714    
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:
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Vitamin D Deficiency
Hypocalcemia
Hypoparathyroidism
Avitaminosis
Deficiency Diseases
Malnutrition
 Nutrition Disorders
Parathyroid Diseases
Endocrine System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance