CClinicalTrials.gg
Status unknownNCT03063060Updated Feb 24, 2017

The Impact of Vitamin D Deficiency on Hypocalcaemia Following Total Thyroidectomy

An observational study in Hypocalcemia and Vitamin D Deficiency, sponsored by Hillel Yaffe Medical Center. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-24.

Sponsored by Hillel Yaffe Medical Center · Observational

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

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

  1. To identify a correlation between pre-operative vitamin D deficiency and the occurrence of hypocalcaemia following total thyroidectomy.
  2. 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.

02

Conditions studied

  • Hypocalcemia
  • Vitamin D Deficiency
03

In context

Vitamin D Deficiency

772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.

This study's planned enrollment of 60 is below the median of 138 across 183 observational studies indexed under Vitamin D Deficiency.

Browse Vitamin D Deficiency studies →

Lead sponsor

Hillel Yaffe Medical Center is the lead sponsor of 301 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Patients with either hypocalcaemia or hypercalcemia before surgery.
  • Patients with Grave's disease.
  • Patients with renal, lung or bone cancer.
  • Pregnancy.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: vitamin D levels and Calcium levels examination

Interventions

  • Othervitamin D levels and Calcium levels examination

    observational

06

What researchers measure

Primary outcomes

  1. Vitamin D levels

    ng/ml

    Time frame: pre- operative vitamin D levels 1 month prior to surgery

  2. Calcium levels

    mg/dl

    Time frame: post operative Ca levels at the day of the surgery

  3. Calcium levels

    mg/dl

    Time frame: post operative Ca levels 1 day after the surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03063060
Lead sponsor
Hillel Yaffe Medical Center
Responsible party
Prof. Ahud Sternberg (Chairman of ethics board, Hillel Yaffe Medical Center) — Principal investigator
First posted
Feb 24, 2017
Start date
Mar 1, 2017 (estimated)
Primary completion
Mar 1, 2018 (estimated)
Completion
Mar 1, 2018 (estimated)
Last update
Feb 24, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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