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
1 other identifier
interventional
124
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2026
CompletedFirst Submitted
Initial submission to the registry
May 13, 2026
CompletedFirst Posted
Study publicly available on registry
May 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
May 19, 2026
May 1, 2026
2 months
May 13, 2026
May 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of postoperative symptomatic hypocalcemia
3 month
Study Arms (2)
Preoperative Calcium and Vitamin D3 Supplementation
ACTIVE COMPARATORParticipants 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 COMPARATORParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- A) Cardiovascular disease B) Deranged Renal parameters C) Pregnancy D) Concomitant endocrine pathology warranting the surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Hospital Lahorecollaborator
- King Edward Medical Universitylead
Study Sites (1)
King Edward Medical University
Lahore, Punjab Province, 54000, Pakistan
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmad Rauf, MBBS
KEMU
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2026
First Posted
May 19, 2026
Study Start
May 10, 2026
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
May 19, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
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.