Vitamin D Levels and Postoperative Hypocalcemia After Total Thyroidectomy

• Sponsor: Aristotle University Of Thessaloniki (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01039714
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 40.3

Study Details

Study Description

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	Intervention/Treatment	Phase
Hypocalcemia; Hypoparathyroidism; Vitamin D Deficiency; Thyroidectomy

Study Design

• Study Type: Observational
• Anticipated 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: Dec 1, 2009
• Anticipated Primary Completion Date: Apr 1, 2010
• Anticipated Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Total Thyroidectomy

Outcome Measures

Primary Outcome Measures

1. Impact of preoperative vitamin D levels on postoperative hypocalcemia after total thyroidectomy. [24 hours postoperatively]

Secondary Outcome Measures

1. Impact of preoperative vitamin D levels on parathyroid function after total thyroidectomy. [24 hours postoperatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	AHEPA University Hospital Thessaloniki, Greece	Thessaloniki	Makedonia	Greece

Sponsors and Collaborators

• Aristotle University Of Thessaloniki

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Erbil Y, Barbaros U, Temel B, Turkoglu U, Işsever H, Bozbora A, Ozarmağan 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.

• ClinicalTrials.gov Identifier: NCT01039714
• Other Study ID Numbers: GXKVITD1
• First Posted: Dec 25, 2009
• Last Update Posted: Dec 25, 2009
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: Hypocalcemia; Hypoparathyroidism; Vitamin D deficiency; Total thyroidectomy; calcium; PTH
• Additional relevant MeSH terms: Vitamin D Deficiency; Hypocalcemia; Hypoparathyroidism

Study Results

No Results Posted as of Dec 25, 2009