Thyroid DiseasesEarly Phase 1NCT04094493
Vit D Role in Post Thyroidectomy Hypocalcemia
A Early Phase 1 study testing vit D in people with Thyroid Diseases, run by Assiut University at 1 site in Egypt.
Trial summary
Hypocalcemia after total thyroidectomy is usually transient but it is of main concern as it requires either prolonged stay in the hospital or readmission. During the first 24 hours bleeding is the main complication, but from the second day to six months, transient hypocalcemia is of main concern. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Diseases
- What is being tested?
- vit D
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 30 Sep 2020
- Phase
- Early Phase 1
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- informed consent
- patient age: > 18 years
- surgical indication for total thyroidectomy
- normal preoperative serum calcium level
Who cannot join
- Low preoperative calcium level
- Renal impairment
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut university
Asyut, 71511
Mohammed Safwat, 01025555420, msafwat67@aun.edu.eg
About this study
Official title: Role of Pre Operative Vit D Administiration in Decrease Incidence of Post Thyroidectomy Hypocalcemia
Hypocalcemia after total thyroidectomy is usually transient but it is of main concern as it requires either prolonged stay in the hospital or readmission. During the first 24 hours bleeding is the main complication, but from the second day to six months, transient hypocalcemia is of main concern. Hypocalcemia can be evaluated symptomatically as well as from laboratory testing. Signs and symptoms of hypocalcemia include numbness, tingling, and carpopedal spasm. Preoperative vitamin D prevents postoperative transient hypocalcemia after thyroidectomy .
Read the detailed description
Thyroid surgery is one of the most frequently performed surgical procedures worldwide . Nowadays, total thyroidectomy is the recommended procedure for thyroid disease . As total thyroidectomy is the procedure of choice, the most common complication resulting after this surgery is transient hypocalcemia - the incidence being 24% - which increases the morbidity rate and increases the length of hospitalization . Other complications of thyroidectomy include recurrent laryngeal nerve injury which leads to hoarseness of voice, postoperative hemorrhage, dysphagia due to inflammation of the tissues surrounding the esophagus, seroma formation, Horner's syndrome due to injury to the cervical sympathetic chain, and poor healing of the wound with hypertrophy of the scar or wound infection .
Advances in surgical techniques have evolved to preserve the parathyroid gland function, which helps to prevent permanent hypocalcemia and its incidence now has reduced to 1-2% . However, transient hypoparathyroidism still occurs resulting in transient hypocalcemia. It occurs due to the age, parathyroid gland handling, devascularization, venous congestion, post-surgical local site edema and neck dissection . Prescribing preoperative vitamin D and calcium decreases the incidence of transient hypocalcemia after total thyroidectomy from 25.9% to 6.8% as compared to the control group .
Total thyroidectomy is the procedure of choice in our population with the preservation of the parathyroid gland. As transient hypocalcemia is common in post-thyroidectomy patients and increases the morbidity rate, giving vitamin D and calcium preoperatively can reduce the burden of postoperative transient hypocalcemia and it will be helpful in decreasing the morbidity rate due to post-thyroidectomy transient hypocalcemia. The objective of our study is to compare the frequency of transient hypocalcemia after vitamin D with the control group for patients undergoing total thyroidectomy.
The study is based on patients with thyroid diseases who are indicated for total thyroidectomy . Patients are divided into two groups : group A who will recieve Vit D before operation and group B who won't . Group A will be divided into :
A1 : no hypocacemia occurs with vit D A2 : hypocalcemia occurs with vit D .
Group B will be divided into:
B1 no hypocacemia without vit D B2 hypocalcemia without vit D . Comparison between the above mentioned four groups will determine the effectiveness of vit D in normalization of serum calcium levels after total thyroidectomy .
- Conditions
- Thyroid Diseases
- Being tested
- vit D
- Keywords
- thyroid - thyroidectomy - hypocalcemia - Vit D administiration
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vit DDrug
preoperative intra muscular vit D injection
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | vit D + no hypocalcemia Receives: Drug: vit D |
| A2 | Experimental | Vit D + hypocalcemia Receives: Drug: vit D |
| B1 | No intervention | NO vit D + no hypocalcemia |
| B2 | No intervention | NO vit D + hypocalcemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum calcium level
normal serum calcium level above 8.8 is the target
Measured: 2nd day post operatively
Appearance of hypocalcemic tetany
numbness , tingling or carpopedal spasm are undesirable clinical presentation of hypocalcemia
Measured: 2nd day post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Thyroid DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ramadan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094493
- Sponsor's protocol ID
- pre-thyroidectomy vit D
- Status last verified
- Sep 2019
- First submitted
- 17 Sep 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan 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 31494332Xing T, Hu Y, Wang B, Zhu J. Role of oral calcium supplementation alone or with vitamin D in preventing post-thyroidectomy hypocalcaemia: A meta-analysis. Medicine (Baltimore). 2019 Feb;98(8):e14455. doi: 10.1097/MD.0000000000014455.
PubMed 30813146Soares CSP, Tagliarini JV, Mazeto GMFS. Preoperative vitamin D level as a post-total thyroidectomy hypocalcemia predictor: a prospective study. Braz J Otorhinolaryngol. 2021 Jan-Feb;87(1):85-89. doi: 10.1016/j.bjorl.2019.07.001. Epub 2019 Aug 6.
PubMed 31492617Cherian AJ, Ponraj S, Gowri S M, Ramakant P, Paul TV, Abraham DT, Paul MJ. The role of vitamin D in post-thyroidectomy hypocalcemia: Still an enigma. Surgery. 2016 Feb;159(2):532-8. doi: 10.1016/j.surg.2015.08.014. Epub 2015 Sep 11.
PubMed 26365947Docimo G, Tolone S, Pasquali D, Conzo G, D'Alessandro A, Casalino G, Gili S, Brusciano L, Gubitosi A, Del Genio G, Ruggiero R, Docimo L. Role of pre and post-operative oral calcium and vitamin D supplements in prevention of hypocalcemia after total thyroidectomy. G Chir. 2012 Nov-Dec;33(11-12):374-8.
PubMed 23140919
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Pre Operative Vit D Administiration in Decrease Incidence of Post Thyroidectomy Hypocalcemia
- ClinicalTrials.gov ID
- NCT04094493
- Acronym / sponsor ID
- pre-thyroidectomy vit D
- Conditions
- Thyroid Diseases
- Keywords
- thyroid - thyroidectomy - hypocalcemia - Vit D administiration
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 19 Sep 2019 (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.
Hypocalcemia after total thyroidectomy is usually transient but it is of main concern as it requires either prolonged stay in the hospital or readmission. During the first 24 hours bleeding is the main complication, but from the second day to six months, transient hypocalcemia is of main concern. Hypocalcemia can be evaluated symptomatically as well as from laboratory testing. Signs and symptoms of hypocalcemia include numbness, tingling, and carpopedal spasm. Preoperative vitamin D prevents postoperative transient hypocalcemia after thyroidectomy .
Detailed description
Thyroid surgery is one of the most frequently performed surgical procedures worldwide . Nowadays, total thyroidectomy is the recommended procedure for thyroid disease . As total thyroidectomy is the procedure of choice, the most common complication resulting after this surgery is transient hypocalcemia - the incidence being 24% - which increases the morbidity rate and increases the length of hospitalization . Other complications of thyroidectomy include recurrent laryngeal nerve injury which leads to hoarseness of voice, postoperative hemorrhage, dysphagia due to inflammation of the tissues surrounding the esophagus, seroma formation, Horner's syndrome due to injury to the cervical sympathetic chain, and poor healing of the wound with hypertrophy of the scar or wound infection .
Advances in surgical techniques have evolved to preserve the parathyroid gland function, which helps to prevent permanent hypocalcemia and its incidence now has reduced to 1-2% . However, transient hypoparathyroidism still occurs resulting in transient hypocalcemia. It occurs due to the age, parathyroid gland handling, devascularization, venous congestion, post-surgical local site edema and neck dissection . Prescribing preoperative vitamin D and calcium decreases the incidence of transient hypocalcemia after total thyroidectomy from 25.9% to 6.8% as compared to the control group .
Total thyroidectomy is the procedure of choice in our population with the preservation of the parathyroid gland. As transient hypocalcemia is common in post-thyroidectomy patients and increases the morbidity rate, giving vitamin D and calcium preoperatively can reduce the burden of postoperative transient hypocalcemia and it will be helpful in decreasing the morbidity rate due to post-thyroidectomy transient hypocalcemia. The objective of our study is to compare the frequency of transient hypocalcemia after vitamin D with the control group for patients undergoing total thyroidectomy.
The study is based on patients with thyroid diseases who are indicated for total thyroidectomy . Patients are divided into two groups : group A who will recieve Vit D before operation and group B who won't . Group A will be divided into :
A1 : no hypocacemia occurs with vit D A2 : hypocalcemia occurs with vit D .
Group B will be divided into:
B1 no hypocacemia without vit D B2 hypocalcemia without vit D . Comparison between the above mentioned four groups will determine the effectiveness of vit D in normalization of serum calcium levels after total thyroidectomy .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: vit Dvit D + no hypocalcemia |
| A2 | Experimental | Drug: vit DVit D + hypocalcemia |
| B1 | No intervention | –NO vit D + no hypocalcemia |
| B2 | No intervention | –NO vit D + hypocalcemia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- informed consent
- patient age: > 18 years
- surgical indication for total thyroidectomy
- normal preoperative serum calcium level
Key exclusion criteria (2 listed)
- Low preoperative calcium level
- Renal impairment
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 |
|---|---|---|
| vit Dpreoperative intra muscular vit D injection | Drug | A1, A2 |
Primary outcome
Serum calcium level
Time frame: 2nd day post operatively
normal serum calcium level above 8.8 is the target
Appearance of hypocalcemic tetany
Time frame: 2nd day post operatively
numbness , tingling or carpopedal spasm are undesirable clinical presentation of hypocalcemia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- 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 30813146Xing T, Hu Y, Wang B, Zhu J. Role of oral calcium supplementation alone or with vitamin D in preventing post-thyroidectomy hypocalcaemia: A meta-analysis. Medicine (Baltimore). 2019 Feb;98(8):e14455. doi: 10.1097/MD.0000000000014455.
- Results publication: PubMed 31492617Soares CSP, Tagliarini JV, Mazeto GMFS. Preoperative vitamin D level as a post-total thyroidectomy hypocalcemia predictor: a prospective study. Braz J Otorhinolaryngol. 2021 Jan-Feb;87(1):85-89. doi: 10.1016/j.bjorl.2019.07.001. Epub 2019 Aug 6.
- Results publication: PubMed 26365947Cherian AJ, Ponraj S, Gowri S M, Ramakant P, Paul TV, Abraham DT, Paul MJ. The role of vitamin D in post-thyroidectomy hypocalcemia: Still an enigma. Surgery. 2016 Feb;159(2):532-8. doi: 10.1016/j.surg.2015.08.014. Epub 2015 Sep 11.
- Results publication: PubMed 23140919Docimo G, Tolone S, Pasquali D, Conzo G, D'Alessandro A, Casalino G, Gili S, Brusciano L, Gubitosi A, Del Genio G, Ruggiero R, Docimo L. Role of pre and post-operative oral calcium and vitamin D supplements in prevention of hypocalcemia after total thyroidectomy. G Chir. 2012 Nov-Dec;33(11-12):374-8.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing vit D in people with Thyroid Diseases, run by Assiut University at 1 site in Egypt.
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 4 inclusion and 2 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 19 Sep 2019. 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 Egypt. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mohammed Ramadan (01024529525, mhmdramdan93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum calcium level (time frame: 2nd day post operatively). The study lists 2 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 NCT04094493, which also lists 5 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 19 Sep 2019.