Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Preoperative Aqueous Iodine Solution for Patients with Hyperthyroidism Due to Graves' Disease and Toxic Nodular Goiter

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for Hyperthyroidism, specifically in conditions known as Graves' disease and toxic nodular goiter. The treatment being tested is a solution called Lugol's solution, which contains iodine. The purpose of the study is to determine if this iodine solution can be safely used in patients with toxic nodular goiter and to see how it affects thyroid hormones and overall health. Additionally, the study aims to find out if using Lugol's solution before surgery can reduce the risk of a temporary condition called hypoparathyroidism after the surgery.

The study is divided into two parts: a pilot study and a main study. In the pilot study, participants with toxic nodular goiter will receive the iodine solution for 10 days. During this time, researchers will monitor changes in thyroid hormone levels and heart rate. In the main study, participants with either toxic nodular goiter or Graves' disease who are scheduled for thyroid surgery will receive the iodine solution before their operation. The researchers will then observe if there is a reduction in the risk of temporary hypoparathyroidism after the surgery.

Throughout the study, participants' quality of life will also be evaluated. The main study will additionally look at the occurrence of permanent hypoparathyroidism and any issues with the nerves that control the voice, known as recurrent nerve palsy, both temporarily and permanently. The study is expected to continue until August 2025, with the aim of providing valuable insights into the preoperative use of iodine solution in these thyroid conditions.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on age (18-75 years) and diagnosis of hyperthyroidism due to toxic nodular goiter or Graves' disease.

    Participation is confirmed for those accepted for thyroid surgery.

  2. Step 2

    Administration of iodine solution

    The study involves the administration of an iodine solution taken orally.

    The iodine solution is administered over a period of 10 days.

  3. Step 3

    Monitoring during iodine administration

    Monitoring includes measuring levels of thyroid hormones such as TSH, fT4, and fT3, as well as heart rate.

    Measurements are taken on day 0, day 3-4, day 6-7, and day 10 of iodine administration.

  4. Step 4

    Surgery preparation

    For participants undergoing thyroid surgery, the effect of the iodine solution on reducing postoperative risks is evaluated.

    The focus is on reducing the risk of temporary hypoparathyroidism after surgery.

  5. Step 5

    Postoperative monitoring

    Postoperative monitoring occurs immediately after surgery and one month post-surgery.

    The occurrence of temporary and permanent hypoparathyroidism and nerve palsy is evaluated.

  6. Step 6

    Evaluation of quality of life

    The study includes an evaluation of the quality of life after treatment with the iodine solution.

    This evaluation helps understand the impact of the treatment on daily living.

Who can join the trial?

6 criteria

  • The patient must have **hyperthyroidism**. This means their thyroid gland is overactive and produces too many hormones.
  • The hyperthyroidism should be due to **toxic nodular goiter**. This is a condition where lumps in the thyroid gland cause it to become overactive.
  • For the main study, the patient can also have **Graves' disease**. This is another condition that causes the thyroid to be overactive.
  • The patient must be between the ages of 18 and 75 years old.
  • The patient must be accepted for a **thyroidectomy**. This is a surgery to remove all or part of the thyroid gland.
  • Both male and female patients can participate.

Who cannot join the trial?

8 criteria

  • Patients who are pregnant or breastfeeding cannot participate.
  • Individuals with severe heart problems are excluded.
  • People with kidney disease that affects how the kidneys work are not allowed to join.
  • Anyone with a history of allergic reactions to iodine or similar substances cannot take part.
  • Participants who have had recent surgery on the thyroid gland are excluded.
  • Individuals currently taking medications that affect thyroid function are not eligible.
  • Patients with other serious health conditions that might interfere with the study are not allowed.
  • People who are unable to follow the study procedures or attend follow-up visits are excluded.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Lugol's Solution Lugol's Solution is an iodine solution used in this clinical trial to study its effects on patients with Graves' disease and toxic nodular goiter. The trial aims to determine if this iodine solution can be safely administered to these patients and how it affects their thyroid hormones and overall clinical status. Additionally, the study investigates whether preoperative treatment with Lugol's Solution can reduce the risk of temporary hypoparathyroidism after thyroid surgery in these patients.

What is already known about the treatment

Lugol's Solution – Lugol's Solution is administered orally, typically in liquid form, and is used in the treatment of hyperthyroidism, particularly in conditions like Graves' disease and toxic nodular goiter. It is currently being studied for its effects on thyroid hormone levels and clinical status in patients with these conditions, as well as its potential to reduce postoperative complications such as temporary hypoparathyroidism. The solution works by providing iodine, which helps to decrease the production of thyroid hormones by the thyroid gland. It is classified as an iodine supplement in pharmacology.

Investigated diseases

Hyperthyroidism – Hyperthyroidism is a condition where the thyroid gland produces too much thyroid hormone, leading to an overactive metabolism. This can cause symptoms such as rapid heartbeat, weight loss, increased appetite, and nervousness. The condition often results from disorders like Graves' disease or toxic nodular goiter. As the disease progresses, individuals may experience increased sweating, tremors, and fatigue. The excessive hormone levels can also lead to changes in menstrual patterns and difficulty sleeping. Over time, untreated hyperthyroidism can lead to more severe complications affecting the heart and bones.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517110-15-00Protocol codeLugolProtocol001Estimated enrolment182 patientsSponsorKarolinska University Hospital

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.