Ongoing Clinical Trials for Hypocalcaemia
There are currently 2 clinical trials investigating ways to prevent and manage low blood calcium levels following thyroid surgery. Both trials are taking place in France and focus on different approaches to reducing the risk of hypocalcaemia after total thyroid removal.
Clinical trial locations
- France
Study of Indocyanine Green Angiography to Prevent Hypoparathyroidism in Patients Undergoing Total Thyroid Removal
This trial investigates whether using a special imaging dye during thyroid surgery can help prevent low calcium levels afterward. The study uses indocyanine green, a substance that glows under special infrared light, allowing surgeons to see blood vessels and the parathyroid glands more clearly during the operation.
Main inclusion criteria: You must be an adult between 18 and 65 years old who needs complete removal of the thyroid gland. You must be able to understand and agree to the study procedures, have active health insurance coverage, and sign an informed consent form. Both men and women can participate.
Main exclusion criteria: You cannot join if you are under 18 or over 65 years old, have had previous thyroid surgery, already have low calcium levels before surgery, are allergic to indocyanine green, are pregnant or breastfeeding, have kidney disease, or take medications that affect calcium levels. People with serious heart, liver, or blood disorders, or those with parathyroid gland problems are also excluded.
Trial focus: The study aims to determine whether using indocyanine green imaging during surgery helps surgeons better identify and preserve the parathyroid glands, which are small glands near the thyroid that control calcium levels in the body. By protecting these glands during surgery, the trial hopes to reduce the occurrence of low calcium levels after the procedure. During surgery, some patients receive an injection of indocyanine green at a dose of up to 0.5 milligrams per kilogram of body weight, while others undergo standard surgery without the dye. Patients are monitored for up to 6 months after surgery, with blood calcium levels checked regularly at 48 hours, day 8, 1 month, and 6 months following the operation.
Investigational treatment: The main substance being tested is indocyanine green, a medical dye that helps surgeons see blood vessels and tissues more clearly during surgery. When injected into the bloodstream and viewed under special infrared light, it makes it easier for surgeons to locate and preserve the parathyroid glands. The trial also monitors blood albumin levels, a protein that helps transport calcium in the body, to correctly interpret calcium measurements.
Study on Preventing Low Calcium Levels After Thyroid Surgery with Preoperative Cholecalciferol Supplementation for Patients Undergoing Total Thyroidectomy
This trial examines whether taking vitamin D supplements before thyroid surgery can help prevent low calcium levels afterward. The study investigates whether preparing the body with cholecalciferol, a form of vitamin D, before the operation can reduce the chances of developing complications related to calcium balance.
Main inclusion criteria: You must be at least 18 years old and scheduled for complete removal of the thyroid gland for any medical reason. You need to provide written informed consent and be affiliated with the social security system. Both men and women can participate in this study.
Main exclusion criteria: You cannot participate if you have not had your thyroid gland removed, are not experiencing low calcium levels after surgery, are not taking vitamin D supplements before surgery, or belong to a vulnerable population that might need special protection or care.
Trial focus: The study investigates whether taking cholecalciferol before surgery can help the body respond better to changes in calcium levels that occur after thyroid removal. Participants receive an oral solution called UVEDOSE 100,000 UI containing cholecalciferol before their surgery. After the operation, their calcium levels are closely monitored for signs of low calcium, such as tingling in the fingers or around the mouth, muscle spasms, or numbness. The monitoring period extends for 15 days after surgery, during which blood calcium levels and any symptoms are carefully tracked. The study also evaluates how long patients stay in the hospital and whether they need additional treatments, such as calcium gluconate, to manage low calcium levels.
Investigational treatment: Cholecalciferol is a form of vitamin D that helps the body absorb calcium from the intestines. By boosting vitamin D levels before the operation, the study aims to increase the body’s ability to maintain normal calcium levels after surgery. This approach targets the underlying mechanism that can lead to low calcium after thyroid removal, potentially reducing complications and improving recovery.
Summary
Both ongoing clinical trials for preventing low calcium levels after thyroid surgery are being conducted in France. These studies take different approaches to the same problem: one focuses on protecting the parathyroid glands during surgery using advanced imaging technology, while the other aims to prepare the body before surgery with vitamin D supplementation. The trials demonstrate medical interest in reducing complications from thyroid surgery through both surgical technique improvements and preventive supplementation. Both studies monitor patients carefully after surgery, tracking calcium levels and symptoms to evaluate the effectiveness of their respective interventions. These trials offer hope for better outcomes and shorter hospital stays for patients undergoing complete thyroid removal.