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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Symptomatic Hypocalcemia Following Total Thyroidectomy
• Intervention / Treatment: Drug: Calcium carbonate plus vitamin D3 (cholecalciferol)

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 Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ali Raza, MBBS; Phone Number: +923406600052; Email: dralirazasial777@gmail.com
• Study Contact Backup: Name: Ahmad Rauf, MBBS; Phone Number: +923006023465; Email: ahmadrauf498@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • King Edward Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 .

D) ASA grade 1 &2 E) With preserved one or two parathyroid gland

Exclusion Criteria:

• A) Cardiovascular disease B) Deranged Renal parameters C) Pregnancy D) Concomitant endocrine pathology warranting the surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Preoperative Calcium and Vitamin D3 Supplementation; 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.	Drug: 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.
Active Comparator: Participants in this arm will receive oral calcium carbonate (500-1000 mg, two to three times daily); 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of postoperative symptomatic hypocalcemia	3 month

Collaborators and Investigators

• Sponsor: King Edward Medical University
• Collaborators: Mayo Hospital Lahore
• Investigators: Principal Investigator: Ahmad Rauf, MBBS, KEMU

Publications and helpful links

Helpful Links

• Database of peer-reviewed studies on thyroidectomy and postoperative hypocalcemia.

Study record dates

Study Major Dates

• Study Start (Estimated): May 10, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Total thyroidectomy Postoperative hypocalcemia Symptomatic hypocalcemia Calcium supplementation Vitamin D3 (cholecalciferol) Preoperative supplementation
• Additional Relevant MeSH Terms: Lipids; Polycyclic Compounds; Inorganic Chemicals; Steroids; Fused-Ring Compounds; Minerals; Calcium Compounds; Cholestenes; Cholestanes; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Carbon Compounds, Inorganic; Carbonates; Carbonic Acid; Calcium Carbonate; Cholecalciferol
• Other Study ID Numbers: Dr Ali Raza

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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 Data/Documents

1. Informed Consent Form

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No