Vitamin D Levels and Postoperative Hypocalcemia After Total Thyroidectomy

Preoperative Vitamin D Levels as a Prognostic Factor for Postoperative Hypocalcemia and Hypoparathyroidism After Total Thyroidectomy

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.

Study Overview

• Status: Unknown
• Conditions: Vitamin D Deficiency; Hypocalcemia; Hypoparathyroidism; Thyroidectomy

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Theodossis S Papavramidis, MD, PhD; Phone Number: 00302310993197; Email: papavramidis@hotmail.com
• Study Contact Backup: Name: Olympia E Anastasiou, MD; Phone Number: 00302310993197; Email: olympia_anastasiou@yahoo.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Total Thyroidectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Impact of preoperative vitamin D levels on postoperative hypocalcemia after total thyroidectomy.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Impact of preoperative vitamin D levels on parathyroid function after total thyroidectomy.	24 hours postoperatively

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Erbil Y, Barbaros U, Temel B, Turkoglu U, Issever H, Bozbora A, Ozarmagan 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Anticipated): April 1, 2010
• Study Completion (Anticipated): May 1, 2010

Study Registration Dates

• First Submitted: September 29, 2009
• First Submitted That Met QC Criteria: December 24, 2009
• First Posted (Estimate): December 25, 2009

Study Record Updates

• Last Update Posted (Estimate): December 25, 2009
• Last Update Submitted That Met QC Criteria: December 24, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Vitamin D deficiency; Hypocalcemia; Hypoparathyroidism; calcium; Total thyroidectomy; PTH
• Additional Relevant MeSH Terms: Metabolic Diseases; Endocrine System Diseases; Nutrition Disorders; Parathyroid Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Calcium Metabolism Disorders; Water-Electrolyte Imbalance; Vitamin D Deficiency; Hypoparathyroidism; Hypocalcemia
• Other Study ID Numbers: GXKVITD1