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

NCT04856488 | Recruiting Phase 3

• 1 other identifier: LugolProtocol001
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hyperthyroidism

Outcome Measures

Primary Outcomes (1)

• Temporary hypoparathyroidism

  Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low parathormone (PTH), supplementation with per oral vitamin D or calcium.

  1 month postoperatively

Secondary Outcomes (3)

• Temporary laryngeal nerve palsy

  1 month postoperatively

• Permanent laryngeal nerve palsy

  6 months postoperatively

• Permanent hypoparathyroidism

  6 months postoperatively

Other Outcomes (1)

• Change from Baseline in Quality of Life on the Thyroid Specific Patient Reported Outcome 39 (ThyPRO 29) questionnaire

  6 months postoperatively

Study Arms (2)

Iodine Potassium Iodide solution

EXPERIMENTAL

Participants receive Iodine Potassium Iodide solution oral drops 3 times per day for 10 Days prior to thyroidectomy in addition to standard preoperative treatment

Drug: Iodine-Potassium Iodide 5%-10% Oral and Topical Solution

No intervention

NO INTERVENTION

Participants continue with standard preoperative treatment

Interventions

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

Iodine Potassium Iodide 5% oral solution, administered 3 times per day for 10 days

Also known as: Lugol's solution

Iodine Potassium Iodide solution

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hyperthyroidism accepted for thyroidectomy due to toxic nodular goiter with free T4 \<30 pmol/L or Graves' disease
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Jan Calissendorff: lead

Study Sites (1)

Department of Endocrinology, Karolinska University Hospital

Solna, Stockholm County, 17176, Sweden

RECRUITING

Related Publications (12)

• Ross DS, Burch HB, Cooper DS, Greenlee MC, Laurberg P, Maia AL, Rivkees SA, Samuels M, Sosa JA, Stan MN, Walter MA. 2016 American Thyroid Association Guidelines for Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis. Thyroid. 2016 Oct;26(10):1343-1421. doi: 10.1089/thy.2016.0229.

  PMID: 27521067 BACKGROUND

• Kaur S, Parr JH, Ramsay ID, Hennebry TM, Jarvis KJ, Lester E. Effect of preoperative iodine in patients with Graves' disease controlled with antithyroid drugs and thyroxine. Ann R Coll Surg Engl. 1988 May;70(3):123-7.

  PMID: 2457351 BACKGROUND

• Randle RW, Bates MF, Long KL, Pitt SC, Schneider DF, Sippel RS. Impact of potassium iodide on thyroidectomy for Graves' disease: Implications for safety and operative difficulty. Surgery. 2018 Jan;163(1):68-72. doi: 10.1016/j.surg.2017.03.030. Epub 2017 Nov 3.

  PMID: 29108701 BACKGROUND

• Whalen G, Sullivan M, Maranda L, Quinlan R, Larkin A. Randomized trial of a short course of preoperative potassium iodide in patients undergoing thyroidectomy for Graves' disease. Am J Surg. 2017 Apr;213(4):805-809. doi: 10.1016/j.amjsurg.2016.07.015. Epub 2016 Aug 4.

  PMID: 27769543 BACKGROUND

• Marigold JH, Morgan AK, Earle DJ, Young AE, Croft DN. Lugol's iodine: its effect on thyroid blood flow in patients with thyrotoxicosis. Br J Surg. 1985 Jan;72(1):45-7. doi: 10.1002/bjs.1800720118.

  PMID: 3967130 BACKGROUND

• Yilmaz Y, Kamer KE, Ureyen O, Sari E, Acar T, Karahalli O. The effect of preoperative Lugol's iodine on intraoperative bleeding in patients with hyperthyroidism. Ann Med Surg (Lond). 2016 Jun 16;9:53-7. doi: 10.1016/j.amsu.2016.06.002. eCollection 2016 Aug.

  PMID: 27408715 BACKGROUND

• Huang SM, Liao WT, Lin CF, Sun HS, Chow NH. Effectiveness and Mechanism of Preoperative Lugol Solution for Reducing Thyroid Blood Flow in Patients with Euthyroid Graves' Disease. World J Surg. 2016 Mar;40(3):505-9. doi: 10.1007/s00268-015-3298-8.

  PMID: 26546192 BACKGROUND

• Calissendorff J, Falhammar H. Rescue pre-operative treatment with Lugol's solution in uncontrolled Graves' disease. Endocr Connect. 2017 May;6(4):200-205. doi: 10.1530/EC-17-0025. Epub 2017 Mar 21.

  PMID: 28325735 BACKGROUND

• Calissendorff J, Falhammar H. Lugol's solution and other iodide preparations: perspectives and research directions in Graves' disease. Endocrine. 2017 Dec;58(3):467-473. doi: 10.1007/s12020-017-1461-8. Epub 2017 Oct 26.

  PMID: 29075974 BACKGROUND

• Spallek L, Krille L, Reiners C, Schneider R, Yamashita S, Zeeb H. Adverse effects of iodine thyroid blocking: a systematic review. Radiat Prot Dosimetry. 2012 Jul;150(3):267-77. doi: 10.1093/rpd/ncr400. Epub 2011 Oct 20.

  PMID: 22021061 BACKGROUND

• Nauman J, Wolff J. Iodide prophylaxis in Poland after the Chernobyl reactor accident: benefits and risks. Am J Med. 1993 May;94(5):524-532. doi: 10.1016/0002-9343(93)90089-8. No abstract available.

  PMID: 8498398 BACKGROUND

• Hedberg F, Cramon PK, Branstrom R, Falhammar H, Calissendorff J. Assessing the impact of short-term Lugol's solution on toxic nodular thyroid disease: a pre-post-intervention study. Front Endocrinol (Lausanne). 2024 Jul 25;15:1420154. doi: 10.3389/fendo.2024.1420154. eCollection 2024.

  PMID: 39119004 DERIVED

MeSH Terms

Conditions

Hyperthyroidism

Interventions

iodine potassium iodide; Solutions; Lugol's solution

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Jan Calissendorff, MD, PhD

  Department of Molecular Medicine and Surgery, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Calissendorff, MD, PhD

CONTACT

+46(0)8 51770000; jan.calissendorff@regionstockholm.se

Fredric Hedberg, MD

CONTACT

+46(0)8 51770000; fredric.hedberg@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Senior Consultant, PhD, Associate Professor

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 23, 2021
• Study Start: November 18, 2021
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The original contributions presented in the study are included in the article/supplementary material. Inquiries can be directed to the corresponding author after publication.
• Access Criteria: Further inquiries can be directed to the corresponding author.

Locations

SE (1)