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Clinical Trials in Sweden / NCT04856488
Recruiting Phase 3

Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter

NCT04856488 · tracked via the Priya Life Science Sweden tracker
Sponsor
Jan Calissendorff
Phase
Phase 3
Started
2021-11-18
Last updated
2026-02-10

Condition(s) studied

Hyperthyroidism

Investigational drug(s) / intervention(s)

Iodine-Potassium Iodide 5%-10% Oral and Topical Solution →

Iodine-Potassium Iodide 5%-10% Oral and Topical Solution: Iodine Potassium Iodide 5% oral solution, administered 3 times per day for 10 days

Study summary

The purpose of this study is to assess if preoperative treatment with Lugol's solution prior to thyroidectomy can reduce the surgical complications hypoparathyroidism and laryngeal nerve palsy

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Hyperthyroidism accepted for thyroidectomy due to toxic nodular goiter with free T4 \<30 pmol/L or Graves' disease * Signed informed consent Exclusion Criteria: * Unstable coronary artery disease * Previous thyroid surgery * Congestive heart failure * Renal insufficiency * Hepatic failure * Current infection * Treatment with steroids or anticoagulants * Thyroid associated orbitopathy CAS \> 2 * Diabetes mellitus type 1 * Active cancer * Severe psychiatric illness * Amiodarone treatment * Pregnancy * Breast feeding * Women of child bearing potential not using contraceptive * Inability to comprehend the meaning of the study * Iodine hypersensitivity

Primary outcome measure(s)

  • Temporary hypoparathyroidism — 1 month postoperatively
    Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low parathormone (PTH), supplementation with per oral vitamin D or calcium.

Trial sites (1)

FacilityCityRegionStatus
Department of Endocrinology, Karolinska University Hospital Solna Stockholm County Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04856488 on ClinicalTrials.gov ↗ ← All trials in Sweden