Study on Preventing Low Calcium Levels After Thyroid Surgery with Preoperative Cholecalciferol Supplementation for Patients Undergoing Total Thyroidectomy

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What is this study about?

This clinical trial focuses on the condition known as hypocalcemia, which can occur after a surgical procedure called thyroidectomy. A thyroidectomy is a common surgery where the thyroid gland is removed. After this surgery, some patients may experience low levels of calcium in their blood, known as hypocalcemia, which can cause discomfort and require longer hospital stays. The study is investigating whether taking a supplement called cholecalciferol, which is a form of vitamin D, before the surgery can help reduce the chances of developing hypocalcemia afterward.

The treatment being studied is an oral solution called UVEDOSE 100,000 UI, which contains cholecalciferol. Participants in the study will receive this supplement before their thyroidectomy to see if it helps their bodies respond better to the changes in calcium levels after the surgery. The study aims to assess the effect of this pre-operative supplementation on the occurrence of hypocalcemia following the surgery.

Throughout the study, participants will be monitored for signs of hypocalcemia, such as tingling in the fingers or around the mouth, and their calcium levels will be checked. The study will also look at how long participants stay in the hospital, any side effects they experience, and whether they need additional treatments for low calcium levels. The goal is to determine if pre-operative cholecalciferol supplementation can improve recovery and reduce complications after a thyroidectomy.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the study’s purpose and procedures.

You must be at least 18 years old and scheduled for a total thyroidectomy, which is a surgery to remove the thyroid gland.

2 pre-operative supplementation

Before your surgery, you will receive a supplement called cholecalciferol, which is a form of vitamin D. This is to help your body respond better to changes in calcium levels after surgery.

The supplement is provided as an oral solution called UVEDOSE 100 000 UI. You will take this by mouth as directed by the study team.

3 surgery and immediate post-operative period

You will undergo a total thyroidectomy. After the surgery, your calcium levels will be closely monitored to check for hypocalcemia, which is a condition where calcium levels in the blood are low.

The study will measure both serum (blood) calcium levels and any symptoms you might experience, such as tingling in the fingers or around the mouth.

4 monitoring and follow-up

For the first 15 days after your surgery, your calcium levels and any symptoms will be monitored. This includes checking for signs like muscle spasms or numbness.

If necessary, you may receive additional treatment, such as calcium gluconate, to manage low calcium levels.

5 evaluation of outcomes

The study will evaluate the duration of your hospital stay and any adverse events, which are unexpected medical issues that might occur.

Your vitamin D levels will be measured before and after the surgery to assess the effectiveness of the cholecalciferol supplementation.

Who Can Join the Study?

Patient must be 18 years or older.
Patient must be scheduled for a total thyroidectomy, which is a surgery to remove the entire thyroid gland, for any reason.
Patient must provide written informed consent, meaning they agree to participate in the study after being fully informed about it.
Patient must be affiliated with the social security system.

Who Cannot Join the Study?

Patients who have not had their thyroid gland removed (thyroidectomy).
Patients who are not experiencing low calcium levels in the blood after surgery (post-operative hypocalcemia).
Patients who are not taking vitamin D supplements (cholecalciferol) before surgery.
Patients who are not within the specified age range for the study.
Patients who are not male or female, as both genders are included in the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Centre Hospitalier Sud Francilien	Corbeil Essonnes	France
Hopital NOVO	Pontoise	France
Centre Hospitalier Intercommunal De Poissy Saint Germain	St Germain En Laye	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	30.06.2021

Trial locations

Investigated drugs:

Colecalciferol

Cholecalciferol is a form of vitamin D that is often used to help the body absorb calcium. In this clinical trial, patients are given cholecalciferol before undergoing thyroid surgery. The goal is to see if taking this vitamin can help prevent low calcium levels in the blood, which can sometimes happen after the surgery. By boosting vitamin D levels before the operation, doctors hope to reduce the risk of this complication and improve recovery for patients.

Hypocalcemia – Hypocalcemia is a condition characterized by low levels of calcium in the blood. It often occurs after thyroid surgery, such as a thyroidectomy, due to potential damage or removal of the parathyroid glands, which regulate calcium levels. The condition can lead to symptoms like tingling in the fingers, muscle cramps, and spasms. In more severe cases, it can cause numbness around the mouth and in the extremities, as well as muscle stiffness. The progression of hypocalcemia can vary, with symptoms appearing shortly after surgery and potentially lasting for several days. Monitoring calcium levels is crucial to manage and understand the progression of this condition.

Trial ID:

2024-516793-30-00

Protocol code:

CHRD2115

NCT ID:

NCT04775381

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Preventing Low Calcium Levels After Thyroid Surgery with Preoperative Cholecalciferol Supplementation for Patients Undergoing Total Thyroidectomy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?