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Vitamin D Levels and Postoperative Hypocalcemia After Total Thyroidectomy
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Aristotle University Of Thessaloniki.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Aristotle University Of Thessaloniki
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
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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 ]
Secondary Outcome Measures:
- Impact of preoperative vitamin D levels on parathyroid function after total thyroidectomy. [ Time Frame: 24 hours postoperatively ]
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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:
- 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
Exclusion Criteria:
- 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)
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01039714
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 |
Keywords provided by Aristotle University Of Thessaloniki:
|
Hypocalcemia Hypoparathyroidism Vitamin D deficiency |
Total thyroidectomy calcium PTH |
Additional relevant MeSH terms:
|
Vitamin D Deficiency Hypoparathyroidism Hypocalcemia Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Parathyroid Diseases Endocrine System Diseases Calcium Metabolism Disorders |
Metabolic Diseases Water-Electrolyte Imbalance Vitamins Vitamin D Ergocalciferols Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on September 19, 2017