HypocalcemiaNCT01039714
Vitamin D Levels and Postoperative Hypocalcemia After Total Thyroidectomy
An observational study of Hypocalcemia and Hypoparathyroidism, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypocalcemia, Hypoparathyroidism, Vitamin D Deficiency
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2009to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients subjected to total thyroidectomy in Third Surgical Clinic of AHEPA University Hospital
Who may be able to join
- 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
Who cannot join
- Primary hyperparathyroidism
- Primary hypoparathyroidism
- Chronic Renal Failure
- Hypoalbuminemia
- Neck irradiation
- Systematic Diseases (e.g., infections)
Show all 9Show fewer
- Thyroid or parathyroid cancer
- Osteoporosis
- Drugs that influence calcium metabolism (vitamin D analogues, oral calcium supplements, biphosphonates, teriparatide, thiazide diuretics)
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
AHEPA University Hospital Thessaloniki, Greece
Thessaloniki, Makedonia
Theodossis S Papavramidis, MD, PhD
Olympia E Anastasiou, MD
About this study
Official title: 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.
- Conditions
- Hypocalcemia, Hypoparathyroidism, Vitamin D Deficiency, Thyroidectomy
- Keywords
- Hypocalcemia, Hypoparathyroidism, Vitamin D deficiency, Total thyroidectomy, calcium, PTH
- Medical subject headings
- Hypocalcemia, Hypoparathyroidism, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total Thyroidectomy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of preoperative vitamin D levels on postoperative hypocalcemia after total thyroidectomy.
Measured: 24 hours postoperatively
Secondary outcomes (1)
Impact of preoperative vitamin D levels on parathyroid function after total thyroidectomy.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionApr 2010 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypocalcemiaStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Investigators
- Spyros T Papavramidis, Prof, Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039714
- Sponsor's protocol ID
- GXKVITD1
- Status last verified
- Dec 2009
- First submitted
- 29 Sep 2009
- Last updated
- 25 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19324110
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Vitamin D Levels as a Prognostic Factor for Postoperative Hypocalcemia and Hypoparathyroidism After Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT01039714
- Acronym / sponsor ID
- GXKVITD1
- Conditions
- Hypocalcemia, Hypoparathyroidism, Vitamin D Deficiency, Thyroidectomy
- Keywords
- Hypocalcemia, Hypoparathyroidism, Vitamin D deficiency, Total thyroidectomy, calcium, PTH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 25 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Thyroidectomy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients subjected to total thyroidectomy in Third Surgical Clinic of AHEPA University Hospital
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Primary hyperparathyroidism
- Primary hypoparathyroidism
- Chronic Renal Failure
- Hypoalbuminemia
- Neck irradiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact of preoperative vitamin D levels on postoperative hypocalcemia after total thyroidectomy.
Time frame: 24 hours postoperatively
1 secondary outcome
Impact of preoperative vitamin D levels on parathyroid function after total thyroidectomy.
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2009.
- Background: PubMed 19324110Erbil 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Spyros T Papavramidis, Prof study director
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypocalcemia and Hypoparathyroidism, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Theodossis S Papavramidis, MD, PhD (00302310993197, papavramidis@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of preoperative vitamin D levels on postoperative hypocalcemia after total thyroidectomy. (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01039714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Dec 2009.