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
Information provided by:
Aristotle University Of Thessaloniki Identifier:
First received: September 29, 2009
Last updated: December 24, 2009
Last verified: December 2009
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.

Vitamin D Deficiency

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

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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)
Total Thyroidectomy


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

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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Please refer to this study by its identifier: NCT01039714

Contact: Theodossis S Papavramidis, MD, PhD 00302310993197
Contact: Olympia E Anastasiou, MD 00302310993197

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

Responsible Party: Third Surgical Clinic, AHEPA University Hospital 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:
Vitamin D deficiency
Total thyroidectomy

Additional relevant MeSH terms:
Parathyroid Diseases
Vitamin D Deficiency
Calcium Metabolism Disorders
Deficiency Diseases
Endocrine System Diseases
Metabolic Diseases
Nutrition Disorders
Water-Electrolyte Imbalance
Vitamin D
Bone Density Conservation Agents
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins processed this record on November 27, 2015