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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07597096
Enrollment
124
Registered
2026-05-19
Start date
2026-05-10
Completion date
2026-06-30
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Symptomatic Hypocalcemia Following Total Thyroidectomy

Keywords

Total thyroidectomy Postoperative hypocalcemia Symptomatic hypocalcemia Calcium supplementation Vitamin D3 (cholecalciferol) Preoperative supplementation

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.

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.

Interventions

DRUGCalcium 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.

Sponsors

King Edward Medical University
Lead SponsorOTHER
Mayo Hospital Lahore
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative symptomatic hypocalcemia3 month

Countries

Pakistan

Contacts

CONTACTAli Raza, MBBS
dralirazasial777@gmail.com+923406600052
CONTACTAhmad Rauf, MBBS
ahmadrauf498@gmail.com+923006023465
PRINCIPAL_INVESTIGATORAhmad Rauf, MBBS

KEMU

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026