Total ThyroidectomyprofessorNCT04212533
Preoperative Hypocalcaemia, a Comparative Clinical Trial
A study testing Vitamin D and rice starch tablets in people with Total Thyroidectomy, run by Zagazig University at 1 site in Egypt.
Trial summary
two groups of patients undergoing total thyroidectomy one group received calcium and vit d prophylaxis the other group received no prophylaxis the investigator measured calcium level post and preoperative and development of tetant was recorded Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Thyroidectomy
- What is being tested?
- Vitamin D and rice starch tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 15 Dec 2019
- Phase
- Interventional
- 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
Who may be able to join
- patient undergoing total thyroidectomy
Who cannot join
- Previous thyroid surgery
- Malabsorption diseases
- Pregnancy
- Previous parathyroid disease or surgery
- Vitamin D deficiency
- Renal impairment
- Hypo or hyper calcaemia
- ASA class 3,4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D and Calcium Supplementation to Prevent Post-total Thyroidectomy Hypocalcaemia, a Comparative Clinical Trial
two groups of patients undergoing total thyroidectomy one group received calcium and vit d prophylaxis the other group received no prophylaxis the investigator measured calcium level post and preoperative and development of tetant was recorded
Read the detailed description
This study is randomized controlled trial carried out on 86 patients undergoing total thyroidectomy in the period between January 2018 and November 2019. Patients were randomly allocated into two groups each one 43 patients the first group is the supplementation group where patients received oral vitamin D 40000 IU and calcium tablets 1 g once before surgery.
Patient included in this study are those above 18 years old undergoing total thyroidectomy.
Patients excluded from this study are those with
- Previous thyroid surgery
- Malabsorption diseases
- Pregnancy
- Previous parathyroid disease or surgery
- Vitamin D deficiency
- Renal impairment
- Hypo or hyper calcaemia
- ASA class 3,4 all patients in this study were subjected to thorough history taking full clinical examination, body mass index calculation, proper assessment of the original thyroid disease requiring surgery, preoperative investigations done as usual in addition to serum calcium, serum magnesium, serum vitamin D and serum parathormon level.
Serum calcium and serum parathormon were tested after 6, 12 and 48 postoperative hours, patients were discharged on the third postoperative day except if further hospitalization was indicated, after discharge patients were followed up in the outpatient clinic by one of the surgical team, serum calcium and parathormon level were tested after1 months, 3 months and after 6th months.
The primary outcome of this study is the development of hypocalcaemia either clinically or laboratory.
Clinical hypocalcaemia means development of perioral and \ or acral tingling and numbness, twitches of the perioral region on tapping in front of the ear" Chvostec's sign'', muscle twitches and development of carpopedal spasm.
Laboratory hypocalcaemia means serum calcium level below 8.5 mg\dl. Secondary outcome is the postoperative parathormon level. Preoperative data, postoperative clinical follow up and laboratory data were collected and analyzed using SPSS 22 program package.
Principles of total thyroidectomy; Total thyroidectomy was performed under general anesthesia, through lower neck collar incision, skin and platysma muscle flap was raised till the thyroid cartilage, opening the midline raphe, exploration of each thyroid lobe and tracing the inferior thyroid artery while emerging from underneath the carotid artery, the inferior thyroid artery was identified with its branches supplying the parathyroid gland, which was identified and preserved with its blood supply, the recurrent laryngeal nerve was searched for in the triangle between the carotid artery , trachea and the inferior thyroid artery. The external laryngeal nerve was identified and preserved 1 cm superior to the upper thyroid pole. If radical thyroidectomy was deemed the same principles of preserving parathyroid glands and their blood supply, recurrent and external laryngeal nerves. If the surgeons ere sure of damaging or removing the parathyroid glands a half of one of them was minced and transplanted in the subcutaneous tissue of the left forearm
- Conditions
- Total Thyroidectomy
- Being tested
- Vitamin D, rice starch tablets
- Keywords
- hypocalcaemia, thyroidectomy, vit D, calcium
- Medical subject headings
- Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called calcium supplementation
comparison between pre- and postoperative calcium and vitamin d level after vit d and calcium supplementation
rice starch tabletsDietary supplement
rice starch tablets as placebo
| Study group | Role | What they receive |
|---|---|---|
| supplementation arm | Active comparator | 43 patients undergoing total thyroidectomy received 40000 IU vit D and once before operation and 500mg calcium tab 4 times in the day before surgery Receives: Dietary Supplement: Vitamin D |
| non-supplementation arm | Active comparator | 43 patients undergoing total thyroidectomy received rice starch tablets /6 hrs in the day before surgery Receives: Dietary Supplement: rice starch tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with hypocalcemia
calcium level below 8.5 mg\dl measured by serum calcium assay
Measured: 24 hrs post operative
number of participants with hypocalcaemia
calcium level below 8.5 mg\dl measured by serum calcium assay
Measured: after 7 days post operative
Secondary outcomes (2)
number of participants with decreased parathormone level below normal level
level of parathormone below 10 pg/mL
Measured: ( 1st month post operative)
number of participants with tetany
development of tingling, numbness or carpopedal spasm measured by clinical examination and patient history
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study start1 Jan 2018
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total ThyroidectomyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two parallel groups each one 43 patients undergoing total thyroidectomy one received prophylactic vitamin d and calcium before surgery the other received nothing , calcium level, vit d levels measured preand postoperative , clinical assessment of patients postoperatie for development of tetany
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hazem Nour Abdellatif, Zagazig University
- Investigators
- hazem nour, Principal investigator, zag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212533
- Sponsor's protocol ID
- hazem nour ca++
- Acronym
- professor
- Status last verified
- Dec 2019
- First submitted
- 22 Dec 2019
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Calcium Supplementation to Prevent Post-total Thyroidectomy Hypocalcaemia, a Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT04212533
- Acronym / sponsor ID
- professor / hazem nour ca++
- Conditions
- Total Thyroidectomy
- Keywords
- hypocalcaemia, thyroidectomy, vit D, calcium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 27 Dec 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.
two groups of patients undergoing total thyroidectomy one group received calcium and vit d prophylaxis the other group received no prophylaxis the investigator measured calcium level post and preoperative and development of tetant was recorded
Detailed description
This study is randomized controlled trial carried out on 86 patients undergoing total thyroidectomy in the period between January 2018 and November 2019. Patients were randomly allocated into two groups each one 43 patients the first group is the supplementation group where patients received oral vitamin D 40000 IU and calcium tablets 1 g once before surgery.
Patient included in this study are those above 18 years old undergoing total thyroidectomy.
Patients excluded from this study are those with
- Previous thyroid surgery
- Malabsorption diseases
- Pregnancy
- Previous parathyroid disease or surgery
- Vitamin D deficiency
- Renal impairment
- Hypo or hyper calcaemia
- ASA class 3,4 all patients in this study were subjected to thorough history taking full clinical examination, body mass index calculation, proper assessment of the original thyroid disease requiring surgery, preoperative investigations done as usual in addition to serum calcium, serum magnesium, serum vitamin D and serum parathormon level.
Serum calcium and serum parathormon were tested after 6, 12 and 48 postoperative hours, patients were discharged on the third postoperative day except if further hospitalization was indicated, after discharge patients were followed up in the outpatient clinic by one of the surgical team, serum calcium and parathormon level were tested after1 months, 3 months and after 6th months.
The primary outcome of this study is the development of hypocalcaemia either clinically or laboratory.
Clinical hypocalcaemia means development of perioral and \ or acral tingling and numbness, twitches of the perioral region on tapping in front of the ear" Chvostec's sign'', muscle twitches and development of carpopedal spasm.
Laboratory hypocalcaemia means serum calcium level below 8.5 mg\dl. Secondary outcome is the postoperative parathormon level. Preoperative data, postoperative clinical follow up and laboratory data were collected and analyzed using SPSS 22 program package.
Principles of total thyroidectomy; Total thyroidectomy was performed under general anesthesia, through lower neck collar incision, skin and platysma muscle flap was raised till the thyroid cartilage, opening the midline raphe, exploration of each thyroid lobe and tracing the inferior thyroid artery while emerging from underneath the carotid artery, the inferior thyroid artery was identified with its branches supplying the parathyroid gland, which was identified and preserved with its blood supply, the recurrent laryngeal nerve was searched for in the triangle between the carotid artery , trachea and the inferior thyroid artery. The external laryngeal nerve was identified and preserved 1 cm superior to the upper thyroid pole. If radical thyroidectomy was deemed the same principles of preserving parathyroid glands and their blood supply, recurrent and external laryngeal nerves. If the surgeons ere sure of damaging or removing the parathyroid glands a half of one of them was minced and transplanted in the subcutaneous tissue of the left forearm
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two parallel groups each one 43 patients undergoing total thyroidectomy one received prophylactic vitamin d and calcium before surgery the other received nothing , calcium level, vit d levels measured preand postoperative , clinical assessment of patients postoperatie for development of tetany
| Arm | Type | Receives |
|---|---|---|
| supplementation arm | Active comparator | Dietary Supplement: Vitamin D43 patients undergoing total thyroidectomy received 40000 IU vit D and once before operation and 500mg calcium tab 4 times in the day before surgery |
| non-supplementation arm | Active comparator | Dietary Supplement: rice starch tablets43 patients undergoing total thyroidectomy received rice starch tablets /6 hrs in the day before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient undergoing total thyroidectomy
Key exclusion criteria (8 listed)
- Previous thyroid surgery
- Malabsorption diseases
- Pregnancy
- Previous parathyroid disease or surgery
- Vitamin D deficiency
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 DAlso: calcium supplementationcomparison between pre- and postoperative calcium and vitamin d level after vit d and calcium supplementation | Dietary supplement | supplementation arm |
| rice starch tabletsrice starch tablets as placebo | Dietary supplement | non-supplementation arm |
Primary outcome
number of participants with hypocalcemia
Time frame: 24 hrs post operative
calcium level below 8.5 mg\dl measured by serum calcium assay
number of participants with hypocalcaemia
Time frame: after 7 days post operative
calcium level below 8.5 mg\dl measured by serum calcium assay
2 secondary outcomes
number of participants with decreased parathormone level below normal level
Time frame: ( 1st month post operative)
number of participants with tetany
Time frame: 1 week
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 27 Dec 2019.
- Individual participant dataSharing planned: No
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COMPARISON OF THE EFFICACY BETWEEN PREOPERATIVE CALCIUM & VITAMIN D3 VERSUS CALCIUM SUPPLEMENTATION ALONE TO PREVENT POST OPERATIVE SYMPTOMATIC HYPOCALCEMIA AFTER TOTAL THYROIDECTOMY IN EUTHYROID PATIENTS
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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.
hazem nour principal investigator
zag university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D and rice starch tablets in people with Total Thyroidectomy, run by Zagazig 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 1 inclusion and 8 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 27 Dec 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.
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?
number of participants with hypocalcemia (time frame: 24 hrs post operative). 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?
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 27 Dec 2019; AzTrials last refreshed its copy on 29 Oct 2026.