Vitamin D Levels and Postoperative Hypocalcemia After Total Thyroidectomy

NCT01039714 | Unknown

• 1 other identifier: GXKVITD1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypocalcemia; Hypoparathyroidism; Vitamin D Deficiency; Thyroidectomy

Keywords

Hypocalcemia; Hypoparathyroidism; Vitamin D deficiency; Total thyroidectomy; calcium; PTH

Outcome Measures

Primary Outcomes (1)

• Impact of preoperative vitamin D levels on postoperative hypocalcemia after total thyroidectomy.

  24 hours postoperatively

Secondary Outcomes (1)

• Impact of preoperative vitamin D levels on parathyroid function after total thyroidectomy.

  24 hours postoperatively

Study Arms (1)

Total Thyroidectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patient is over 18 years old
• Patient scheduled for total thyroidectomy
• Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures

You may not qualify if:

• Primary hyperparathyroidism
• Primary hypoparathyroidism
• Chronic Renal Failure
• Hypoalbuminemia
• Neck irradiation
• Systematic Diseases (e.g., infections)
• Thyroid or parathyroid cancer
• Osteoporosis
• Drugs that influence calcium metabolism (vitamin D analogues, oral calcium supplements, biphosphonates, teriparatide, thiazide diuretics)

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

AHEPA University Hospital Thessaloniki, Greece

Thessaloniki, Makedonia, Greece

RECRUITING

Related 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.

  PMID: 19324110 BACKGROUND

MeSH Terms

Conditions

Hypocalcemia; Hypoparathyroidism; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Parathyroid Diseases; Endocrine System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Study Officials

• Spyros T Papavramidis, Prof

  Aristotle University Of Thessaloniki

  STUDY DIRECTOR

Central Study Contacts

Theodossis S Papavramidis, MD, PhD

CONTACT

00302310993197; papavramidis@hotmail.com

Olympia E Anastasiou, MD

CONTACT

00302310993197; olympia_anastasiou@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: December 25, 2009
• Study Start: December 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 25, 2009

Record last verified: 2009-12

Locations

GR (1)