NCT07597096

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

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress25%
May 2026Jun 2026

Study Start

First participant enrolled

May 10, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 13, 2026

Last Update Submit

May 13, 2026

Conditions

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative symptomatic hypocalcemia

    3 month

Study Arms (2)

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.

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.

Drug: Calcium carbonate plus vitamin D3 (cholecalciferol)

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.

Participants in this arm will receive oral calcium carbonate (500-1000 mg, two to three times daily)Preoperative Calcium and Vitamin D3 Supplementation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Links

MeSH Terms

Interventions

Calcium CarbonateCholecalciferol

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMineralsCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Ahmad Rauf, MBBS

    KEMU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
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.

Available IPD Datasets

Informed Consent Form Access

Locations