Clinical Trials Logo

Clinical 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.

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03063060
Study type Observational
Source Hillel Yaffe Medical Center
Contact
Status Not yet recruiting
Phase N/A
Start date March 1, 2017
Completion date March 1, 2018

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04244474 - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children Phase 1/Phase 2
Recruiting NCT05459298 - ViDES Trial (Vitamin D Extra Supplementation) N/A
Completed NCT04476511 - The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules Phase 3
Suspended NCT03652987 - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed NCT03920150 - Vitamin D 24'000 IU for Oral Intermittent Supplementation Phase 3
Completed NCT03264625 - The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis Phase 2
Completed NCT04183257 - Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics Phase 4
Recruiting NCT05084248 - Vitamin D Deficiency in Adults Following a Major Burn Injury Phase 4
Completed NCT05506696 - Vitamin D Supplementation Study N/A
Completed NCT00092066 - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227) Phase 3
Completed NCT03234218 - Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study
Completed NCT02714361 - A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women N/A
Completed NCT03203382 - Corneal Nerve Structure in Sjogren's
Completed NCT02906319 - Vitamin D and HbA1c Levels in Diabetic Patients With CKD N/A
Completed NCT02118129 - Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'. N/A
Completed NCT02187146 - The Effects of Serum Vitamin D and IVF Outcome N/A
Not yet recruiting NCT01419821 - Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5 N/A
Completed NCT02275650 - The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter N/A
Completed NCT01651000 - Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency Phase 3
Completed NCT01741181 - Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2 Phase 4