Total ThyroidectomyPhase 4NCT05216419
Prevention of Postoperative Hypocalcemia of Oral Vitamin D Supplementation Before Total Thyroidectomy
A Phase 4 study testing Cholecalciferol in people with Total Thyroidectomy and Hypocalcemia, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
The hypocalcemia after total thyroidectomy is one of common surgical complications. It may be asymptomatic, but patients can complain of dysfunction around the mouth or extremities, stiffness or convulsion in severe cases. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Total Thyroidectomy, Hypocalcemia, Vitamin D Deficiency
- What is being tested?
- Cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 7 Jun 2021to 16 Oct 2024
- Phase
- Phase 4
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 19 to 70 years old
- Patients undergoing total thyroidectomy due to thyroid disease
- Patients who consented to the study and obtained consent for the study
Who cannot join
- Patients with confirmed hypocalcemia or hypercalcemia before surgery
- Patients receiving calcium or vitamin D treatment before surgery, patients with excessive vitamin D
- Patients with a previous history of parathyroid disease or a history of cervical irradiation
- Patients with confirmed parathyroid comorbidity
- Patients with diseases or conditions that cause hypercalcemia or hypercalciuria (myeloma, bone metastases, or other malignant bone diseases)
- Patients with confirmed renal dysfunction (glomerular filtration rate <60mL/min/1.73m2) before surgery or with a history of chronic renal failure
Show all 17Show fewer
- Renal stone disease patient, kidney stone disease patient
- Patients with bowel disease that may affect serum vitamin D levels (celiac disease, small intestine resorption disease, small bowel resection history)
- Patients taking drugs that may affect serum calcium or vitamin D levels (anticonvulsants, bisphosphonates, cisplatin, aminoglycosides, diuretics, proton pump inhibitors, glucocorticoid benzodiazepine derivatives, etc.)
- Uncontrolled hypertension, diabetes, and clotting disorders
- Cardiovascular disease (angina pectoris, heart failure, myocardial infarction, coronary artery disease, history of arrhythmia treatment, stroke, transient ischemic attack), and taking medications for arrhythmia
- Drug Abuse and Alcohol Abuse
- Patients who participated in other drug clinical trials within 30 days
- Patients with a history of allergies to drugs
- For women, pregnant and lactating patients
- Patients judged unsuitable by the person in charge of the clinical trial
- Patients with genetic problems such as galactose intolerance, lactose deficiency, or glucose-galactose malabsorption disorder
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Chung-Ang University Hospital
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: Study for Effectiveness in Prevention of Postoperative Hypocalcemia of Preoperative Oral Supplementation of Vitamin D (D-mac 30,000 IU) in Patients Undergoing Total Thyroidectomy
The hypocalcemia after total thyroidectomy is one of common surgical complications. It may be asymptomatic, but patients can complain of dysfunction around the mouth or extremities, stiffness or convulsion in severe cases. The incidence of transient hypocalcemia was 6.9-46%, and permanent hypocalcemia was reported to be 0.4-33%. It has been reported that the incidence of hypocalcemia after thyroidectomy is high when the difference in blood levels of parathyroid hormone and vitamin D is large before and after surgery.
Therefore, it is a very important task to study the effect of using vitamin D3 (cholecalciferol), which has a better effect on the human body, on the prevention of hypocalcemia after total thyroidectomy with a long follow-up period after surgery. The department of surgery in Seoul National University Hospital intends to analyze the preventive effect "D-mac 30,000 IU" on postoperative hypocalcemia and safety of 'D-mac 30,000 IU" through a prospective randomized clinical trial.
Read more
The incidence of postoperative hypocalcemia of the group taking orally taking vitamin D3 (cholecalciferol) before surgery will be compared with that of the group not taking vitamin D3 before surgery. Patients who are enrolled in this RCT are allocated to the case group and the control group. Patients in the case group are taking 30,000 IU of vitamin D3 (cholecalciferol) orally, and patients in the control group are not taking any drugs.
Primary endpoint of this study is to evaluate the incidence of hypocalcemia. And secondary endpoints are to evaluate the recovery duration from postoperative hypocalcemia and the risk factors for postoperative hypocalcemia.
- Conditions
- Total Thyroidectomy, Hypocalcemia, Vitamin D Deficiency
- Being tested
- Cholecalciferol
- 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.
CholecalciferolDrug
Since the concentration of "D-mac 30,000 IU" in the body reaches the maximum in the body around 1 to 3 weeks after administration, the drug is taken once 15 days before the surgery so that the vitamin D3 concentration is maximized at the time of surgery.
In the case of the control group, there is no drug to be taken.
| Study group | Role | What they receive |
|---|---|---|
| case group | Experimental | One dose of "30,000 IU of D-mac" is taken once 15 days prior to surgery. Receives: Drug: Cholecalciferol |
| control group | No intervention | There is no "30,000 IU of D-mac" to be taken. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hypocalcemia
The incidence of hypocalcemia at postoperative 1 day
Measured: postoperative 1 day
Postoperative hypocalcemia
The incidence of hypocalcemia at postoperative 2 weeks
Measured: postoperative 2 weeks
Postoperative hypocalcemia
The incidence of hypocalcemia at postoperative 3 months
Measured: postoperative 3 months
Postoperative hypocalcemia
The incidence of hypocalcemia at postoperative 6 months
Measured: postoperative 6 months
Secondary outcomes (3)
The occurrence of hypocalcemia sign
The results of survey about the occurrence of hypocalcemia sign
Measured: 1 day, 2 weeks, 3 months, 6 months after surgery
Duration of recovery period from postoperative hypocalcemia
Duration for recovery from hypocalcemia after thyroidectomy
Measured: 1 day, 2 weeks, 3 months, 6 months after surgery
Risk factors for developing postoperative hypocalcemia
Risk factors associated with postoperative hypocalcemia
Measured: 1 day, 2 weeks, 3 months, 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start7 Jun 2021
- Primary completion16 Oct 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Total ThyroidectomyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Since the concentration of "D-mac 30,000 IU" in the body reaches the maximum in the body around 1 to 3 weeks after administration, the drug is taken once 15 days before the surgery so that the vitamin D3 concentration is maximized at the time of surgery. In the case of the control group, there is no drug to be taken.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dalim BioTech Co., Ltd.
- Responsible party
- Principal investigator, Su-jin Kim, Seoul National University Hospital
- Investigators
- Su-Jin Kim, M.D., Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216419
- Sponsor's protocol ID
- 2103-050-1203
- Status last verified
- Apr 2025
- First submitted
- 10 May 2021
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bahn Chair RS, Burch HB, Cooper DS, Garber JR, Greenlee MC, Klein I, Laurberg P, McDougall IR, Montori VM, Rivkees SA, Ross DS, Sosa JA, Stan MN; American Thyroid Association; American Association of Clinical Endocrinologists. Hyperthyroidism and other causes of thyrotoxicosis: management guidelines of the American Thyroid Association and American Association of Clinical Endocrinologists. Thyroid. 2011 Jun;21(6):593-646. doi: 10.1089/thy.2010.0417. Epub 2011 Apr 21.
PubMed 21510801Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
PubMed 26462967Ozbas S, Kocak S, Aydintug S, Cakmak A, Demirkiran MA, Wishart GC. Comparison of the complications of subtotal, near total and total thyroidectomy in the surgical management of multinodular goitre. Endocr J. 2005 Apr;52(2):199-205. doi: 10.1507/endocrj.52.199.
PubMed 15863948Edafe O, Antakia R, Laskar N, Uttley L, Balasubramanian SP. Systematic review and meta-analysis of predictors of post-thyroidectomy hypocalcaemia. Br J Surg. 2014 Mar;101(4):307-20. doi: 10.1002/bjs.9384. Epub 2014 Jan 9.
PubMed 24402815Alshahrani F, Aljohani N. Vitamin D: deficiency, sufficiency and toxicity. Nutrients. 2013 Sep 13;5(9):3605-16. doi: 10.3390/nu5093605.
PubMed 24067388Lee GH, Ku YH, Kim HI, Lee MC, Kim MJ. Vitamin D level is not a predictor of hypocalcemia after total thyroidectomy. Langenbecks Arch Surg. 2015 Jul;400(5):617-22. doi: 10.1007/s00423-015-1311-1. Epub 2015 Jun 9.
PubMed 26050997Thomusch O, Machens A, Sekulla C, Ukkat J, Brauckhoff M, Dralle H. The impact of surgical technique on postoperative hypoparathyroidism in bilateral thyroid surgery: a multivariate analysis of 5846 consecutive patients. Surgery. 2003 Feb;133(2):180-5. doi: 10.1067/msy.2003.61.
PubMed 12605179Khan Bhettani M, Rehman M, Ahmed M, Altaf HN, Choudry UK, Khan KH. Role of pre-operative vitamin D supplementation to reduce post-thyroidectomy hypocalcemia; Cohort study. Int J Surg. 2019 Nov;71:85-90. doi: 10.1016/j.ijsu.2019.08.035. Epub 2019 Sep 5.
PubMed 31494332Malik MZ, Mirza AA, Farooqi SA, Chaudhary NA, Waqar M, Bhatti HW. Role of Preoperative Administration of Vitamin D and Calcium in Postoperative Transient Hypocalcemia after Total Thyroidectomy. Cureus. 2019 Apr 30;11(4):e4579. doi: 10.7759/cureus.4579.
PubMed 31281762
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for Effectiveness in Prevention of Postoperative Hypocalcemia of Preoperative Oral Supplementation of Vitamin D (D-mac 30,000 IU) in Patients Undergoing Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT05216419
- Acronym / sponsor ID
- 2103-050-1203
- Conditions
- Total Thyroidectomy, Hypocalcemia, Vitamin D Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Dalim BioTech Co., Ltd.
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 31 Jan 2022 (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.
The hypocalcemia after total thyroidectomy is one of common surgical complications. It may be asymptomatic, but patients can complain of dysfunction around the mouth or extremities, stiffness or convulsion in severe cases. The incidence of transient hypocalcemia was 6.9-46%, and permanent hypocalcemia was reported to be 0.4-33%. It has been reported that the incidence of hypocalcemia after thyroidectomy is high when the difference in blood levels of parathyroid hormone and vitamin D is large before and after surgery.
Therefore, it is a very important task to study the effect of using vitamin D3 (cholecalciferol), which has a better effect on the human body, on the prevention of hypocalcemia after total thyroidectomy with a long follow-up period after surgery. The department of surgery in Seoul National University Hospital intends to analyze the preventive effect "D-mac 30,000 IU" on postoperative hypocalcemia and safety of 'D-mac 30,000 IU" through a prospective randomized clinical trial.
The incidence of postoperative hypocalcemia of the group taking orally taking vitamin D3 (cholecalciferol) before surgery will be compared with that of the group not taking vitamin D3 before surgery. Patients who are enrolled in this RCT are allocated to the case group and the control group. Patients in the case group are taking 30,000 IU of vitamin D3 (cholecalciferol) orally, and patients in the control group are not taking any drugs.
Primary endpoint of this study is to evaluate the incidence of hypocalcemia. And secondary endpoints are to evaluate the recovery duration from postoperative hypocalcemia and the risk factors for postoperative hypocalcemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Since the concentration of "D-mac 30,000 IU" in the body reaches the maximum in the body around 1 to 3 weeks after administration, the drug is taken once 15 days before the surgery so that the vitamin D3 concentration is maximized at the time of surgery. In the case of the control group, there is no drug to be taken.
| Arm | Type | Receives |
|---|---|---|
| case group | Experimental | Drug: CholecalciferolOne dose of "30,000 IU of D-mac" is taken once 15 days prior to surgery. |
| control group | No intervention | –There is no "30,000 IU of D-mac" to be taken. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 19 to 70 years old
- Patients undergoing total thyroidectomy due to thyroid disease
- Patients who consented to the study and obtained consent for the study
Key exclusion criteria (17 listed)
- Patients with confirmed hypocalcemia or hypercalcemia before surgery
- Patients receiving calcium or vitamin D treatment before surgery, patients with excessive vitamin D
- Patients with a previous history of parathyroid disease or a history of cervical irradiation
- Patients with confirmed parathyroid comorbidity
- Patients with diseases or conditions that cause hypercalcemia or hypercalciuria (myeloma, bone metastases, or other malignant bone diseases)
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 |
|---|---|---|
| CholecalciferolSince the concentration of "D-mac 30,000 IU" in the body reaches the maximum in the body around 1 to 3 weeks after administration, the drug is taken once 15 days before the surgery so that the vitamin D3 concentration is maximized at the time of surgery. In the case of the control group, there is no drug to be taken. | Drug | case group |
Primary outcome
Postoperative hypocalcemia
Time frame: postoperative 1 day
The incidence of hypocalcemia at postoperative 1 day
Postoperative hypocalcemia
Time frame: postoperative 2 weeks
The incidence of hypocalcemia at postoperative 2 weeks
Postoperative hypocalcemia
Time frame: postoperative 3 months
The incidence of hypocalcemia at postoperative 3 months
Postoperative hypocalcemia
Time frame: postoperative 6 months
The incidence of hypocalcemia at postoperative 6 months
3 secondary outcomes
The occurrence of hypocalcemia sign
Time frame: 1 day, 2 weeks, 3 months, 6 months after surgery
Duration of recovery period from postoperative hypocalcemia
Time frame: 1 day, 2 weeks, 3 months, 6 months after surgery
Risk factors for developing postoperative hypocalcemia
Time frame: 1 day, 2 weeks, 3 months, 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background: PubMed 21510801Bahn Chair RS, Burch HB, Cooper DS, Garber JR, Greenlee MC, Klein I, Laurberg P, McDougall IR, Montori VM, Rivkees SA, Ross DS, Sosa JA, Stan MN; American Thyroid Association; American Association of Clinical Endocrinologists. Hyperthyroidism and other causes of thyrotoxicosis: management guidelines of the American Thyroid Association and American Association of Clinical Endocrinologists. Thyroid. 2011 Jun;21(6):593-646. doi: 10.1089/thy.2010.0417. Epub 2011 Apr 21.
- Background: PubMed 26462967Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
- Background: PubMed 15863948Ozbas S, Kocak S, Aydintug S, Cakmak A, Demirkiran MA, Wishart GC. Comparison of the complications of subtotal, near total and total thyroidectomy in the surgical management of multinodular goitre. Endocr J. 2005 Apr;52(2):199-205. doi: 10.1507/endocrj.52.199.
- Background: PubMed 24402815Edafe O, Antakia R, Laskar N, Uttley L, Balasubramanian SP. Systematic review and meta-analysis of predictors of post-thyroidectomy hypocalcaemia. Br J Surg. 2014 Mar;101(4):307-20. doi: 10.1002/bjs.9384. Epub 2014 Jan 9.
- Background: PubMed 24067388Alshahrani F, Aljohani N. Vitamin D: deficiency, sufficiency and toxicity. Nutrients. 2013 Sep 13;5(9):3605-16. doi: 10.3390/nu5093605.
- Results publication: PubMed 26050997Lee GH, Ku YH, Kim HI, Lee MC, Kim MJ. Vitamin D level is not a predictor of hypocalcemia after total thyroidectomy. Langenbecks Arch Surg. 2015 Jul;400(5):617-22. doi: 10.1007/s00423-015-1311-1. Epub 2015 Jun 9.
- Results publication: PubMed 12605179Thomusch O, Machens A, Sekulla C, Ukkat J, Brauckhoff M, Dralle H. The impact of surgical technique on postoperative hypoparathyroidism in bilateral thyroid surgery: a multivariate analysis of 5846 consecutive patients. Surgery. 2003 Feb;133(2):180-5. doi: 10.1067/msy.2003.61.
- Results publication: PubMed 31494332Khan Bhettani M, Rehman M, Ahmed M, Altaf HN, Choudry UK, Khan KH. Role of pre-operative vitamin D supplementation to reduce post-thyroidectomy hypocalcemia; Cohort study. Int J Surg. 2019 Nov;71:85-90. doi: 10.1016/j.ijsu.2019.08.035. Epub 2019 Sep 5.
- Results publication: PubMed 31281762Malik MZ, Mirza AA, Farooqi SA, Chaudhary NA, Waqar M, Bhatti HW. Role of Preoperative Administration of Vitamin D and Calcium in Postoperative Transient Hypocalcemia after Total Thyroidectomy. Cureus. 2019 Apr 30;11(4):e4579. doi: 10.7759/cureus.4579.
- 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.
Su-Jin Kim, M.D., Ph.D principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cholecalciferol in people with Total Thyroidectomy and Hypocalcemia, run by Seoul National University Hospital at 2 sites in South Korea.
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 17 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: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative hypocalcemia (time frame: postoperative 1 day). The study lists 4 primary outcomes in all. 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 NCT05216419, which also lists 9 linked publications.
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 Apr 2025.