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
  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:


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:

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

ClinicalTrials.gov processed this record on August 26, 2014