Postoperative Symptomatic Hypocalcemia Following Total ThyroidectomyNCT07597096
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
A study testing Calcium carbonate plus vitamin D3 (cholecalciferol) in people with Postoperative Symptomatic Hypocalcemia Following Total Thyroidectomy, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
Total thyroidectomy is a commonly performed surgery for thyroid diseases such as multinodular goiter. One of the most frequent complications after this procedure is hypocalcemia (low blood calcium levels), which may cause symptoms such as tingling around the mouth, muscle cramps, and in severe cases, spasms or… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Symptomatic Hypocalcemia Following Total Thyroidectomy
- What is being tested?
- Calcium carbonate plus vitamin D3 (cholecalciferol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 sitePakistan
- Study dates
- 10 May 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A) Age between 18 to 60 years B) Both genders C) Multiple nodular goiter diagnosed on the basis of history and investigation like thyroid function test , USG neck for TIRADS scoring and USG guided FNAC to confirm the diagnosis .
- ASA grade 1 \&2 E) With preserved one or two parathyroid gland
Who cannot join
- A) Cardiovascular disease B) Deranged Renal parameters C) Pregnancy D) Concomitant endocrine pathology warranting the surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Total thyroidectomy is a commonly performed surgery for thyroid diseases such as multinodular goiter. One of the most frequent complications after this procedure is hypocalcemia (low blood calcium levels), which may cause symptoms such as tingling around the mouth, muscle cramps, and in severe cases, spasms or confusion. This condition usually occurs within the first 24-72 hours after surgery and may delay hospital discharge and increase patient discomfort.
This study aims to compare the effectiveness of preoperative calcium plus vitamin D3 supplementation versus calcium supplementation alone in preventing postoperative symptomatic hypocalcemia in patients undergoing total thyroidectomy. Patients diagnosed with multinodular goiter and planned for surgery will be randomly assigned into two groups. One group will receive calcium with vitamin D3 for seven days before surgery, while the other group will receive calcium alone for the same duration.
Read more
After surgery, patients will be monitored for symptoms of hypocalcemia and their serum calcium levels will be checked at 6, 24, and 48 hours, as well as at a follow-up visit on day 14. The main outcome of the study is the occurrence of symptomatic hypocalcemia in both groups.
The results of this study may help determine whether adding vitamin D3 to preoperative calcium supplementation provides better protection against hypocalcemia after thyroid surgery, potentially improving patient outcomes and reducing hospital stay.
Read the detailed description
Total thyroidectomy is a standard surgical procedure performed for benign and malignant thyroid disorders, particularly multinodular goiter. Despite being a safe operation, one of its most common and clinically significant complications is postoperative hypocalcemia, which primarily results from transient or permanent impairment of parathyroid gland function due to devascularization, inadvertent removal, or surgical trauma. Symptomatic hypocalcemia typically occurs within 24-72 hours after surgery and may present with neuromuscular irritability such as perioral numbness, paresthesia, muscle cramps, carpopedal spasm, tetany, or, in severe cases, cardiac arrhythmias. This complication can lead to prolonged hospital stay, increased patient morbidity, and higher healthcare costs.
Various strategies have been proposed to reduce the incidence and severity of post-thyroidectomy hypocalcemia, including routine postoperative calcium supplementation, selective supplementation based on serum calcium or parathyroid hormone levels, and preoperative administration of calcium and vitamin D3. Vitamin D3 plays a key role in calcium homeostasis by enhancing intestinal calcium absorption and improving postoperative calcium balance, potentially reducing the risk of symptomatic hypocalcemia when administered preoperatively along with calcium.
This randomized controlled trial is designed to compare the efficacy of preoperative calcium plus vitamin D3 supplementation versus calcium supplementation alone in preventing postoperative symptomatic hypocalcemia in euthyroid patients undergoing total thyroidectomy for multinodular goiter. Eligible patients will be randomized into two groups: one receiving oral calcium with vitamin D3 and the other receiving oral calcium alone for seven days prior to surgery.
Postoperatively, patients will be closely monitored clinically and biochemically. Serum corrected calcium levels will be measured at 6, 24, and 48 hours after surgery, and again at a 14-day follow-up visit. Parathyroid hormone levels will also be assessed at selected time points. Symptomatic hypocalcemia will be defined based on the presence of clinical features in combination with low serum calcium levels.
The study aims to determine whether preoperative vitamin D3 supplementation provides additional benefit over calcium alone in reducing the incidence of postoperative symptomatic hypocalcemia, thereby improving early postoperative recovery, reducing hospital stay, and optimizing perioperative management in thyroid surgery patients.
- Being tested
- Calcium carbonate plus vitamin D3 (cholecalciferol)
- Keywords
- Total thyroidectomy Postoperative hypocalcemia Symptomatic hypocalcemia Calcium supplementation Vitamin D3 (cholecalciferol) Preoperative supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium carbonate plus vitamin D3 (cholecalciferol)Drug
Participants in this arm will receive oral calcium carbonate (500-1000 mg, two to three times daily) in combination with oral vitamin D3 (cholecalciferol 1000-2000 IU once daily) for 7 days prior to total thyroidectomy. This preoperative supplementation is administered to evaluate its effectiveness in reducing the incidence of postoperative symptomatic hypocalcemia.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Calcium and Vitamin D3 Supplementation | Active comparator | Participants in this arm will receive oral calcium carbonate (500-1000 mg, two to three times daily) along with oral vitamin D3 (cholecalciferol 1000-2000 IU once daily) for 7 days prior to total thyroidectomy. This supplementation is given to assess its effectiveness in reducing postoperative symptomatic hypocalcemia compared to calcium alone. Receives: Drug: Calcium carbonate plus vitamin D3 (cholecalciferol) |
| Participants in this arm will receive oral calcium carbonate (500-1000 mg, two to three times daily) | Active comparator | Participants in this arm will receive oral calcium carbonate (500-1000 mg, two to three times daily) for 7 days prior to total thyroidectomy without vitamin D3 supplementation. This group serves as the control to compare the incidence of postoperative symptomatic hypocalcemia. Receives: Drug: Calcium carbonate plus vitamin D3 (cholecalciferol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative symptomatic hypocalcemia
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start10 May 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Symptomatic Hypocalcemia Following 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
- Participants will be randomly assigned into two parallel groups. Group A will receive preoperative oral calcium with vitamin D3 supplementation, while Group B will receive oral calcium supplementation alone. Outcomes will be compared between the two groups after total thyroidectomy.
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Hospital Lahore
- Responsible party
- Sponsor
- Investigators
- Ahmad Rauf, MBBS, Principal investigator, KEMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597096
- Sponsor's protocol ID
- Dr Ali Raza
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared as this is a single-center academic research study conducted for institutional and postgraduate training purposes. Data will remain confidential and will be used only for analysis and publication within the study team, in accordance with institutional ethical review board guidelines and patient confidentiality policies.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07597096
- Acronym / sponsor ID
- Dr Ali Raza
- Keywords
- Total thyroidectomy Postoperative hypocalcemia Symptomatic hypocalcemia Calcium supplementation Vitamin D3 (cholecalciferol) Preoperative supplementation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Collaborators
- Mayo Hospital Lahore
- Study start
- 10 May 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 May 2026 (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.
Total thyroidectomy is a commonly performed surgery for thyroid diseases such as multinodular goiter. One of the most frequent complications after this procedure is hypocalcemia (low blood calcium levels), which may cause symptoms such as tingling around the mouth, muscle cramps, and in severe cases, spasms or confusion. This condition usually occurs within the first 24-72 hours after surgery and may delay hospital discharge and increase patient discomfort.
This study aims to compare the effectiveness of preoperative calcium plus vitamin D3 supplementation versus calcium supplementation alone in preventing postoperative symptomatic hypocalcemia in patients undergoing total thyroidectomy. Patients diagnosed with multinodular goiter and planned for surgery will be randomly assigned into two groups. One group will receive calcium with vitamin D3 for seven days before surgery, while the other group will receive calcium alone for the same duration.
After surgery, patients will be monitored for symptoms of hypocalcemia and their serum calcium levels will be checked at 6, 24, and 48 hours, as well as at a follow-up visit on day 14. The main outcome of the study is the occurrence of symptomatic hypocalcemia in both groups.
The results of this study may help determine whether adding vitamin D3 to preoperative calcium supplementation provides better protection against hypocalcemia after thyroid surgery, potentially improving patient outcomes and reducing hospital stay.
Detailed description
Total thyroidectomy is a standard surgical procedure performed for benign and malignant thyroid disorders, particularly multinodular goiter. Despite being a safe operation, one of its most common and clinically significant complications is postoperative hypocalcemia, which primarily results from transient or permanent impairment of parathyroid gland function due to devascularization, inadvertent removal, or surgical trauma. Symptomatic hypocalcemia typically occurs within 24-72 hours after surgery and may present with neuromuscular irritability such as perioral numbness, paresthesia, muscle cramps, carpopedal spasm, tetany, or, in severe cases, cardiac arrhythmias. This complication can lead to prolonged hospital stay, increased patient morbidity, and higher healthcare costs.
Various strategies have been proposed to reduce the incidence and severity of post-thyroidectomy hypocalcemia, including routine postoperative calcium supplementation, selective supplementation based on serum calcium or parathyroid hormone levels, and preoperative administration of calcium and vitamin D3. Vitamin D3 plays a key role in calcium homeostasis by enhancing intestinal calcium absorption and improving postoperative calcium balance, potentially reducing the risk of symptomatic hypocalcemia when administered preoperatively along with calcium.
This randomized controlled trial is designed to compare the efficacy of preoperative calcium plus vitamin D3 supplementation versus calcium supplementation alone in preventing postoperative symptomatic hypocalcemia in euthyroid patients undergoing total thyroidectomy for multinodular goiter. Eligible patients will be randomized into two groups: one receiving oral calcium with vitamin D3 and the other receiving oral calcium alone for seven days prior to surgery.
Postoperatively, patients will be closely monitored clinically and biochemically. Serum corrected calcium levels will be measured at 6, 24, and 48 hours after surgery, and again at a 14-day follow-up visit. Parathyroid hormone levels will also be assessed at selected time points. Symptomatic hypocalcemia will be defined based on the presence of clinical features in combination with low serum calcium levels.
The study aims to determine whether preoperative vitamin D3 supplementation provides additional benefit over calcium alone in reducing the incidence of postoperative symptomatic hypocalcemia, thereby improving early postoperative recovery, reducing hospital stay, and optimizing perioperative management in thyroid surgery patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned into two parallel groups. Group A will receive preoperative oral calcium with vitamin D3 supplementation, while Group B will receive oral calcium supplementation alone. Outcomes will be compared between the two groups after total thyroidectomy.
| Arm | Type | Receives |
|---|---|---|
| Preoperative Calcium and Vitamin D3 Supplementation | Active comparator | Drug: Calcium carbonate plus vitamin D3 (cholecalciferol)Participants in this arm will receive oral calcium carbonate (500-1000 mg, two to three times daily) along with oral vitamin D3 (cholecalciferol 1000-2000 IU once daily) for 7 days prior to total thyroidectomy. This supplementation is given to assess its effectiveness in reducing postoperative symptomatic hypocalcemia compared to calcium alone. |
| Participants in this arm will receive oral calcium carbonate (500-1000 mg, two to three times daily) | Active comparator | Drug: Calcium carbonate plus vitamin D3 (cholecalciferol)Participants in this arm will receive oral calcium carbonate (500-1000 mg, two to three times daily) for 7 days prior to total thyroidectomy without vitamin D3 supplementation. This group serves as the control to compare the incidence of postoperative symptomatic hypocalcemia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A) Age between 18 to 60 years B) Both genders C) Multiple nodular goiter diagnosed on the basis of history and investigation like thyroid function test , USG neck for TIRADS scoring and USG guided FNAC to confirm the diagnosis .
- ASA grade 1 \&2 E) With preserved one or two parathyroid gland
Key exclusion criteria (1 listed)
- A) Cardiovascular disease B) Deranged Renal parameters C) Pregnancy D) Concomitant endocrine pathology warranting the surgery
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 |
|---|---|---|
| Calcium carbonate plus vitamin D3 (cholecalciferol)Participants in this arm will receive oral calcium carbonate (500-1000 mg, two to three times daily) in combination with oral vitamin D3 (cholecalciferol 1000-2000 IU once daily) for 7 days prior to total thyroidectomy. This preoperative supplementation is administered to evaluate its effectiveness in reducing the incidence of postoperative symptomatic hypocalcemia. | Drug | Participants in this arm will receive oral calcium carbonate (500-1000 mg, two to three times daily), Preoperative Calcium and Vitamin D3 Supplementation |
Primary outcome
Incidence of postoperative symptomatic hypocalcemia
Time frame: 3 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Database of peer-reviewed studies on thyroidectomy and postoperative hypocalcemia.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared as this is a single-center academic research study conducted for institutional and postgraduate training purposes. Data will remain confidential and will be used only for analysis and publication within the study team, in accordance with institutional ethical review board guidelines and patient confidentiality policies.
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.
Ahmad Rauf, MBBS principal investigator
KEMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium carbonate plus vitamin D3 (cholecalciferol) in people with Postoperative Symptomatic Hypocalcemia Following Total Thyroidectomy, run by King Edward Medical University 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 19 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Raza, MBBS (+923406600052, dralirazasial777@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative symptomatic hypocalcemia (time frame: 3 month). 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 19 May 2026.