HypocalcemiaNCT05586529
Effect of Preoperative High-dose Cholecalciferol in Prevention of Post-thyroidectomy Hypocalcaemia
A study testing Cholecalciferol in people with Hypocalcemia, run by Pak Emirates Military Hospital at 1 site in Pakistan.
Trial summary
Hypocalcaemia after thyroidectomy is observed with increasing frequency, often resulting in prolonged hospital stay with increased use of resources, delayed return to work and reduced quality of life. The administration of vitamin D is essential in the therapy of postoperative hypocalcaemia. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypocalcemia
- What is being tested?
- Cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2022to Dec 2024
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (> 18 years)
- Scheduled for TT
- Thyroid cancer treated with total thyroidectomy without lymph node dissection
Who cannot join
- Lack of written consent
- Thyroid cancer treated with TT and lymph node dissection
- Mediastinal goiter with need for sternotomy
- Medication with thiazide diuretics, digitalis or lithium therapy
- Previous neck operations or radiation
- Preexisting hyperparathyroidism
- Chronic kidney failure.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Pak-Emirates Military Hospital
Rawalpindi, Punjab Province
Mubashra Badar, MBBS, FCPS
About this study
Official title: Effect of Preoperative High-dose Cholecalciferol in Prevention of Post-thyroidectomy Hypocalcaemia : A Randomized Controlled Trial
Hypocalcaemia after thyroidectomy is observed with increasing frequency, often resulting in prolonged hospital stay with increased use of resources, delayed return to work and reduced quality of life. The administration of vitamin D is essential in the therapy of postoperative hypocalcaemia. What has not been examined so far is whether and how routine preoperative cholecalciferol prophylaxis can help to prevent postoperative hypocalcaemia
Read the detailed description
Hypocalcemia following thyroid surgery is caused either due to parathyroid devascularization, stunning, or accidental removal of the parathyroid glandsMultiple risk factors have been identified which predispose patients to develop post-operative hypocalcemia. In light of the available evidence of prevalent vitamin D deficiency in the general population, and the observation of appearance of postthyroidectomy hypocalcemic symptoms at a much earlier stage than documented in previous literature, we postulate that a prophylactic vitamin D supplementation dose given in immediate preoperative period can significantly reduce acute symptomatic postoperative hypocalcemia in patients undergoing thyroid surgery
- Conditions
- Hypocalcemia
- Being tested
- Cholecalciferol
- Keywords
- Cholecalciferol, post-operative hypocalcemia, thyroidectomy
- Medical subject headings
- Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDietary supplement
Also called Indrop-D
Cholecalciferol is vitamin D derivative and as our population already vit D deficient so post-operative hypocalcemia can be prevented.
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol group | Experimental | patients will recieve one dose of Vitamin D 200000 IU PO at the time of admission Receives: Dietary Supplement: Cholecalciferol |
| Control | No intervention | Patients will not recieve any vitamin D before admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative hypocalcemia
The primary outcomes measure of this study was postoperative hypocalcemia based on either clinical symptoms or laboratory values.
Measured: After 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Nov 2022
- Primary completionNov 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypocalcemiaStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pak Emirates Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mubashra Badar, Pak Emirates Military Hospital
- Investigators
- Mubashra Badar, Principal investigator, Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586529
- Sponsor's protocol ID
- Thy 1 cpsp
- Status last verified
- Mar 2023
- First submitted
- 14 Oct 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will publish this article and all the available darra will be available for researchers to view.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative High-dose Cholecalciferol in Prevention of Post-thyroidectomy Hypocalcaemia : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05586529
- Acronym / sponsor ID
- Thy 1 cpsp
- Conditions
- Hypocalcemia
- Keywords
- Cholecalciferol, post-operative hypocalcemia, thyroidectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Pak Emirates Military HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Oct 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.
Hypocalcaemia after thyroidectomy is observed with increasing frequency, often resulting in prolonged hospital stay with increased use of resources, delayed return to work and reduced quality of life. The administration of vitamin D is essential in the therapy of postoperative hypocalcaemia. What has not been examined so far is whether and how routine preoperative cholecalciferol prophylaxis can help to prevent postoperative hypocalcaemia
Detailed description
Hypocalcemia following thyroid surgery is caused either due to parathyroid devascularization, stunning, or accidental removal of the parathyroid glandsMultiple risk factors have been identified which predispose patients to develop post-operative hypocalcemia. In light of the available evidence of prevalent vitamin D deficiency in the general population, and the observation of appearance of postthyroidectomy hypocalcemic symptoms at a much earlier stage than documented in previous literature, we postulate that a prophylactic vitamin D supplementation dose given in immediate preoperative period can significantly reduce acute symptomatic postoperative hypocalcemia in patients undergoing thyroid surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol group | Experimental | Dietary Supplement: Cholecalciferolpatients will recieve one dose of Vitamin D 200000 IU PO at the time of admission |
| Control | No intervention | –Patients will not recieve any vitamin D before admission |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (> 18 years)
- Scheduled for TT
- Thyroid cancer treated with total thyroidectomy without lymph node dissection
Key exclusion criteria (7 listed)
- Lack of written consent
- Thyroid cancer treated with TT and lymph node dissection
- Mediastinal goiter with need for sternotomy
- Medication with thiazide diuretics, digitalis or lithium therapy
- Previous neck operations or radiation
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 |
|---|---|---|
| CholecalciferolAlso: Indrop-DCholecalciferol is vitamin D derivative and as our population already vit D deficient so post-operative hypocalcemia can be prevented. | Dietary supplement | Cholecalciferol group |
Primary outcome
Post-operative hypocalcemia
Time frame: After 6 months
The primary outcomes measure of this study was postoperative hypocalcemia based on either clinical symptoms or laboratory values.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: Yes. Will publish this article and all the available darra will be available for researchers to view.
Related trials for Hypocalcemia
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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.
Mubashra Badar principal investigator
Resident
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol in people with Hypocalcemia, run by Pak Emirates Military Hospital at 1 site in Pakistan.
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 7 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 29 Mar 2023. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mubashra Badar, MBBS (03145274242, mubashrabadar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative hypocalcemia (time frame: After 6 months). 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 29 Mar 2023.