A Phase 3 interventional study of Iodine-Potassium Iodide 5%-10% Oral and Topical Solution in Hyperthyroidism, sponsored by Jan Calissendorff. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Jan Calissendorff · Phase 3, Interventional, and Treatment
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
Current practice in Sweden before thyroidectomy due to hyperthyroidism is preoperative treatment with antithyroid drugs (ATD) to all patients with Graves' disease and in cases of toxic nodular goiter with pronounced hyperthyroidism. Iodine solution is administered preoperatively in selected cases of Graves' disease where ATD is intolerable. In the cases where iodine is used it is in the form of extemporaneous prepared iodine potassium iodide solution (Lugol 5%). The dose varies in clinical studies. In American and Swedish guidelines the dose is 5-10 drops 3 times per day for 10 days prior to surgery. American guidelines recommend iodine as preoperative treatment i Graves' disease but this is based on sparse evidence. Iodine as preoperative treatment in toxic nodular goiter has yet not been studied.
The purpose of this study is to assess if preoperative treatment with Lugol's solution prior to thyroidectomy due to hyperthyroidism reduce the surgical complications hypoparathyroidism and laryngeal nerve palsy.
Before including toxic nodular goiters accepted for surgery, a pilot study will be performed on 20 patients with toxic nodular goiter. They will receive Lugol solution 3 times per day for ten days and thyroid hormone levels will be measured day 0, day 3-4, day 6-7 and after 10 days of Lugol treatment. Heart rate assessed and ThyPRO39 filled out before and after treatment.
112 studies on the registry are indexed under Hyperthyroidism; 27 are open to participants now.
This study's planned enrollment of 182 is above the median of 60 across 61 interventional studies indexed under Hyperthyroidism.
Browse Hyperthyroidism studies →This is the only study on the registry with Jan Calissendorff as lead sponsor.
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Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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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
Participants continue with standard preoperative treatment
Iodine Potassium Iodide 5% oral solution, administered 3 times per day for 10 days
Also known as: Lugol's solution
Temporary hypoparathyroidism
Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low parathormone (PTH), supplementation with per oral vitamin D or calcium.
Time frame: 1 month postoperatively
Temporary laryngeal nerve palsy
Number of patients with postoperative signs of vocal chord damage via clinical assessment or laryngoscopy.
Time frame: 1 month postoperatively
Permanent laryngeal nerve palsy
Number of patients with postoperative signs of vocal chord damage via clinical assessment or laryngoscopy.
Time frame: 6 months postoperatively
Permanent hypoparathyroidism
Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low PTH, supplementation with per oral vitamin D or calcium.
Time frame: 6 months postoperatively
Change from Baseline in Quality of Life on the Thyroid Specific Patient Reported Outcome 39 (ThyPRO 29) questionnaire
ThyPRO 39 is a validated thyroid specific Quality of Life form. Self reported questionnaire filled out before and after surgery. ThyPRO consists of 39 items grouped in 11 scales. Each item is is rated from 0 to 5 on a 5 point Likert scale. Increasing scores indicating decreasing quality of life. Lower scores indicating better quality of life.
Time frame: 6 months postoperatively
Plan to share: Yes — The original contributions presented in the study are included in the article/supplementary material.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
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