Vitamin D Levels and Postoperative Hypocalcemia After Total Thyroidectomy

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01039714
• Other study ID #: GXKVITD1
• Status: Recruiting
• Phase: N/A
• First received: September 29, 2009
• Last updated: December 24, 2009
• Start date: December 2009
• Est. completion date: May 2010

Study information

• Verified date: December 2009
• Source: Aristotle University Of Thessaloniki
• Contact: Theodossis S Papavramidis, MD, PhD
• Phone: 00302310993197
• Email: papavramidis[@]hotmail.com
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypocalcemia
• Hypoparathyroidism
• Thyroidectomy
• Vitamin D Deficiency

Locations

Country	Name	City	State
Greece	AHEPA University Hospital Thessaloniki, Greece	Thessaloniki	Makedonia

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of preoperative vitamin D levels on postoperative hypocalcemia after total thyroidectomy.		24 hours postoperatively	No
Secondary	Impact of preoperative vitamin D levels on parathyroid function after total thyroidectomy.		24 hours postoperatively	No