Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Study of post-total thyroidectomy hypocalcemia after preoperative cholecalciferol supplementation.

This study is investigating if a vitamin D supplement, called cholecalciferol, given before an operation to remove the thyroid gland (a thyroidectomy) can help stop people from getting low calcium levels afterwards. Low calcium after this surgery is quite common and can make patients feel unwell, sometimes leading to longer stays in hospital. The researchers believe that taking vitamin D beforehand might help the body manage its calcium levels better after the operation, potentially leading to a quicker and smoother recovery. This is a large-scale study, trying to confirm these findings.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Hopital NOVO

Enrolment target

200

Start

16 Oct 2024

Thyroidectomy is a common operation. Transient postoperative hypocalcemia is the main complication resulting in clinical discomfort for patients

What is this study about?

When people have an operation to remove all or part of their thyroid gland, it’s quite common for their calcium levels to drop too low afterwards. This is called hypocalcemia. This can make patients feel uncomfortable and sometimes means they have to stay in the hospital for longer than expected. Because of this, hospitals might spend more money on care and medications.

This study is looking into whether giving a vitamin D supplement, specifically cholecalciferol, before the thyroid operation can help prevent these low calcium levels. Vitamin D is really important for helping our bodies absorb and use calcium properly. The researchers think that if a person has enough vitamin D before surgery, their body might be better prepared to handle any changes in calcium after the operation.

The main goal is to see if people who take the vitamin D supplement have fewer problems with low calcium, both in their blood tests and in how they feel. They will also be looking at how long people stay in the hospital, if they need to be readmitted, and how severe any low calcium symptoms might be. Ultimately, this study hopes to find a simple way to make recovery from thyroid surgery easier and more comfortable for patients.

Key takeaways

This study investigates using vitamin D before thyroid surgery.
It aims to prevent or reduce low calcium levels after the operation.
Low calcium can cause discomfort and longer hospital stays.
Participants will receive a vitamin D supplement and be monitored closely.
The study hopes to improve recovery for people having thyroid surgery.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. Both men and women are welcome to participate.

Before joining, the research team will check your full medical history to make sure the study is a good fit for you and that taking part would be safe. This ensures that the study results are clear and reliable.

If you're interested, the study team will discuss all the requirements with you in detail.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you aged 18 or over?
Are you scheduled for a total thyroidectomy (removal of your thyroid gland)?
Are you able to take an oral (by mouth) vitamin D supplement?
Are you willing for your blood calcium and vitamin D levels to be monitored before and after surgery?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be given a vitamin D supplement called UVEDOSE. This comes as a drinkable liquid in a small container. You would take this supplement before your thyroid surgery. The research team would then closely monitor your calcium levels, both through blood tests and by checking for any symptoms, from the time of your surgery up to 15 days afterwards. They will also keep track of how long you stay in the hospital, if you have any side effects, and if you need to be readmitted. They will also measure your vitamin D levels and how your parathyroid glands are working. The total duration of active monitoring for the main part of the study is about 15 days after your surgery.

Potential risks and benefits

Potential benefits of participating could include contributing to medical knowledge that might help future patients have a smoother recovery after thyroid surgery. You might also receive extra monitoring of your calcium and vitamin D levels. As with any medication, there's always a chance of side effects from the vitamin D supplement, although these are generally mild for cholecalciferol. The research team will discuss all known risks with you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is hypocalcemia?

Hypocalcemia means your body has lower than normal levels of calcium. It can cause tingling, muscle cramps, and other symptoms.

Why might I get low calcium after thyroid surgery?

Sometimes, the small glands near your thyroid, called parathyroid glands, can be affected during surgery. These glands help control your calcium levels.

What is cholecalciferol?

Cholecalciferol is a type of vitamin D that helps your body absorb calcium from the food you eat.

Will taking part affect my usual treatment?

No, this study is designed to run alongside your standard care. The research team will ensure your regular treatment is not affected and that you receive the best care possible.

How long will I be monitored for low calcium after surgery?

The study will closely monitor your calcium levels for up to 15 days after your surgery.