HypocalcemiaNCT03063060
The Impact of Vitamin D Deficiency on Hypocalcaemia Following Total Thyroidectomy
An observational study of Hypocalcemia and Vitamin D Deficiency, run by Hillel Yaffe Medical Center.
Trial summary
Post-operative hypocalcaemia following total thyroidectomy is a well-known complication and becoming a major area of research. Many factors are assumed to increase the incidence of post-thyroidectomy hypocalcaemia, but the impact of vitamin D deficiency remains uncertain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypocalcemia, Vitamin D Deficiency
- What is being tested?
- vitamin D levels and Calcium levels examination
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2017to 1 Mar 2018
- 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: A total number of 60 patients underwent total thyroidectomy with available vitamin D levels before surgery, as well as pre and post-operative PTH and calcium levels. Pre-operative vitamin D and PTH levels were checked within a maximum of one month duration before surgery.
Who may be able to join
- Adult patients ≥ 18 years.
- Both males and females.
- Patients who underwent total thyroidectomy.
- Documented 25-hydroxyvitamin D level preoperatively.
- Documented calcium levels pre and postoperatively.
- Documented PTH levels pre and postoperatively.
Who cannot join
- Patients with either hypocalcaemia or hypercalcemia before surgery.
- Patients with Grave's disease.
- Patients with renal, lung or bone cancer.
- Pregnancy.
About this study
Post-operative hypocalcaemia following total thyroidectomy is a well-known complication and becoming a major area of research.
Many factors are assumed to increase the incidence of post-thyroidectomy hypocalcaemia, but the impact of vitamin D deficiency remains uncertain.
Read more
Since results so far were inconclusive, the goal in this study is to significantly determine the relation between those two factors.
This study is the first to deal with this issue through patients who underwent total thyroidectomy that was performed by the same surgeon and the same surgical technique.
A retrospective evaluation study of patients who underwent total thyroidectomy at the head and neck unit of the Otorhinolaryngology department at our institution between January 2013 and October 2016.
A total number of 60 patients underwent total thyroidectomy with available vitamin D levels before surgery, as well as pre and post-operative PTH and calcium levels.
Pre-operative vitamin D and PTH levels were checked within a maximum of one month duration before surgery.
All patients were operated by the same surgeon -Dr. Galit Avior-, with the same surgical technique.
The study involves access to the patients files and admission reports. In addition the investigators would like to be able to call the patients in order to ask them whether Vitamin D deficiency was corrected or not before their surgery, and If it was corrected then when exactly.
Read the detailed description
Background Post-operative hypocalcaemia following total thyroidectomy is a well-known complication and becoming a major area of research.
Many factors are assumed to increase the incidence of post-thyroidectomy hypocalcaemia, but the impact of vitamin D deficiency remains uncertain.
Vitamin D deficiency is known to be one of the most common medical conditions in the world.. Serum calcium is mainly regulated by parathyroid hormone (PTH) and vitamin D, therefore demonstration of a correlation between preoperative vitamin D levels and the occurrence of post thyroidectomy hypocalcaemia may reveal an easily correctable factor.
Recently, few studies have investigated whether preoperative vitamin D levels have any effect on post thyroidectomy hypocalcaemia. Some of them showed that patients with vitamin D deficiency were more likely to develop postoperative hypocalcaemia. In addition a significant decrease in postoperative hypocalcemia was shown in patients who received supplementation of vitamin D regardless of their vitamin D status, while others found no relationship between preoperative vitamin D concentrations and postoperative hypocalcaemia .
Since results so far were inconclusive, the goal in this study is to significantly determine the relation between those two factors.
This study is the first to deal with this issue through patients who underwent total thyroidectomy that was performed by the same surgeon and the same surgical technique.
Study objective
- To identify a correlation between pre-operative vitamin D deficiency and the occurrence of hypocalcaemia following total thyroidectomy.
- To determine wether the correction of vitamin D levels prior to the surgery was able to prevent post surgery hypocalcaemia.
Study design A retrospective evaluation study of patients who underwent total thyroidectomy at the head and neck unit of the Otorhinolaryngology department at our institution between January 2013 and October 2016.
A total number of 60 patients underwent total thyroidectomy with available vitamin D levels before surgery, as well as pre and post-operative PTH and calcium levels.
Pre-operative vitamin D and PTH levels were checked within a maximum of one month duration before surgery.
All patients were operated by the same surgeon -Dr. Galit Avior-, with the same surgical technique.
Methods:
The study involves access to the patients files and admission reports. In addition the investigators would like to be able to call the patients in order to ask them whether Vitamin D deficiency was corrected or not before their surgery, and If it was corrected then when exactly.
- Conditions
- Hypocalcemia, Vitamin D Deficiency
- Being tested
- vitamin D levels and Calcium levels examination
- Medical subject headings
- Hypocalcemia, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D levels and Calcium levels examinationOther
observational
| Study group | Role | What they receive |
|---|---|---|
| total thyroidectomy | patients who underwent total thyroidectomy with available vitamin D levels before surgery, as well as pre and post-operative PTH and calcium levels. Receives: Other: vitamin D levels and Calcium levels examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D levels
ng/ml
Measured: pre- operative vitamin D levels 1 month prior to surgery
Calcium levels
mg/dl
Measured: post operative Ca levels at the day of the surgery
Calcium levels
mg/dl
Measured: post operative Ca levels 1 day after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start1 Mar 2017 (estimated)
- Primary completion1 Mar 2018 (estimated)
- Study completion1 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypocalcemiaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Ahud Sternberg, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063060
- Sponsor's protocol ID
- 0014-17
- Status last verified
- Feb 2017
- First submitted
- 25 Jan 2017
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vitamin D Deficiency on Hypocalcaemia Following Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT03063060
- Acronym / sponsor ID
- 0014-17
- Conditions
- Hypocalcemia, Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 1 Mar 2017 (estimated)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 Mar 2018 (estimated)
- First posted
- 24 Feb 2017 (actual)
- 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.
Post-operative hypocalcaemia following total thyroidectomy is a well-known complication and becoming a major area of research.
Many factors are assumed to increase the incidence of post-thyroidectomy hypocalcaemia, but the impact of vitamin D deficiency remains uncertain.
Since results so far were inconclusive, the goal in this study is to significantly determine the relation between those two factors.
This study is the first to deal with this issue through patients who underwent total thyroidectomy that was performed by the same surgeon and the same surgical technique.
A retrospective evaluation study of patients who underwent total thyroidectomy at the head and neck unit of the Otorhinolaryngology department at our institution between January 2013 and October 2016.
A total number of 60 patients underwent total thyroidectomy with available vitamin D levels before surgery, as well as pre and post-operative PTH and calcium levels.
Pre-operative vitamin D and PTH levels were checked within a maximum of one month duration before surgery.
All patients were operated by the same surgeon -Dr. Galit Avior-, with the same surgical technique.
The study involves access to the patients files and admission reports. In addition the investigators would like to be able to call the patients in order to ask them whether Vitamin D deficiency was corrected or not before their surgery, and If it was corrected then when exactly.
Detailed description
Background Post-operative hypocalcaemia following total thyroidectomy is a well-known complication and becoming a major area of research.
Many factors are assumed to increase the incidence of post-thyroidectomy hypocalcaemia, but the impact of vitamin D deficiency remains uncertain.
Vitamin D deficiency is known to be one of the most common medical conditions in the world.. Serum calcium is mainly regulated by parathyroid hormone (PTH) and vitamin D, therefore demonstration of a correlation between preoperative vitamin D levels and the occurrence of post thyroidectomy hypocalcaemia may reveal an easily correctable factor.
Recently, few studies have investigated whether preoperative vitamin D levels have any effect on post thyroidectomy hypocalcaemia. Some of them showed that patients with vitamin D deficiency were more likely to develop postoperative hypocalcaemia. In addition a significant decrease in postoperative hypocalcemia was shown in patients who received supplementation of vitamin D regardless of their vitamin D status, while others found no relationship between preoperative vitamin D concentrations and postoperative hypocalcaemia .
Since results so far were inconclusive, the goal in this study is to significantly determine the relation between those two factors.
This study is the first to deal with this issue through patients who underwent total thyroidectomy that was performed by the same surgeon and the same surgical technique.
Study objective
- To identify a correlation between pre-operative vitamin D deficiency and the occurrence of hypocalcaemia following total thyroidectomy.
- To determine wether the correction of vitamin D levels prior to the surgery was able to prevent post surgery hypocalcaemia.
Study design A retrospective evaluation study of patients who underwent total thyroidectomy at the head and neck unit of the Otorhinolaryngology department at our institution between January 2013 and October 2016.
A total number of 60 patients underwent total thyroidectomy with available vitamin D levels before surgery, as well as pre and post-operative PTH and calcium levels.
Pre-operative vitamin D and PTH levels were checked within a maximum of one month duration before surgery.
All patients were operated by the same surgeon -Dr. Galit Avior-, with the same surgical technique.
Methods:
The study involves access to the patients files and admission reports. In addition the investigators would like to be able to call the patients in order to ask them whether Vitamin D deficiency was corrected or not before their surgery, and If it was corrected then when exactly.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| total thyroidectomy | – | Other: vitamin D levels and Calcium levels examinationpatients who underwent total thyroidectomy with available vitamin D levels before surgery, as well as pre and post-operative PTH and calcium levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total number of 60 patients underwent total thyroidectomy with available vitamin D levels before surgery, as well as pre and post-operative PTH and calcium levels. Pre-operative vitamin D and PTH levels were checked within a maximum of one month duration before surgery.
Key inclusion criteria (6 listed)
- Adult patients ≥ 18 years.
- Both males and females.
- Patients who underwent total thyroidectomy.
- Documented 25-hydroxyvitamin D level preoperatively.
- Documented calcium levels pre and postoperatively.
Key exclusion criteria (4 listed)
- Patients with either hypocalcaemia or hypercalcemia before surgery.
- Patients with Grave's disease.
- Patients with renal, lung or bone cancer.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin D levels and Calcium levels examinationobservational | Other | total thyroidectomy |
Primary outcome
Vitamin D levels
Time frame: pre- operative vitamin D levels 1 month prior to surgery
ng/ml
Calcium levels
Time frame: post operative Ca levels at the day of the surgery
mg/dl
Calcium levels
Time frame: post operative Ca levels 1 day after the surgery
mg/dl
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypocalcemia and Vitamin D Deficiency, run by Hillel Yaffe Medical Center.
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 6 inclusion and 4 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 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D levels (time frame: pre- operative vitamin D levels 1 month prior to surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2017.