AuthorisedPhase II and Phase III (Integrated)Interventional

Study of hydroxocobalamin at a new concentration for cobalamin-related remethylation disorders.

This research is investigating a new, potentially better strength of hydroxocobalamin, which is a form of vitamin B12. It's designed for people who have health issues because their body can't properly process vitamin B12. The main goal is to see if this new strength helps to lower high levels of a substance called tHcy in the blood. High tHcy levels can sometimes indicate a problem with how your body uses B12. The study will measure these levels carefully at the beginning and then regularly over two years to compare how well different treatments work. By understanding this, doctors hope to find the best ways to help people with these vitamin B12-related conditions feel better.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Fundacion Instituto De Investigacion Sanitaria De Santiago De Compostela

Enrolment target

Start

09 Jun 2025

Hydroxycobalamin deficiency

What is this study about?

This study is specifically designed to explore a new concentration, or strength, of a medicine called hydroxocobalamin. Hydroxocobalamin is a form of vitamin B12, which is really important for many body functions, including making red blood cells and keeping your nervous system healthy. Some people have conditions where their body struggles to use vitamin B12 properly, even if they get enough in their diet. This can lead to various health problems.

The main aim of this research is to see if this new strength of hydroxocobalamin can help people with these specific conditions. Doctors will be checking levels of a substance in the blood called tHcy (which stands for total homocysteine). When the body isn't using vitamin B12 correctly, tHcy levels can go up. So, by measuring tHcy, researchers can get an idea of how well the body is processing vitamin B12 and if the treatment is helping.

By comparing how tHcy levels change in people receiving different treatments, the study hopes to find out if this new strength of hydroxocobalamin is effective and safe. This information is crucial because it could lead to better treatment options for individuals affected by these vitamin B12-related issues, potentially improving their health and quality of life.

Key takeaways

This study is testing a new strength of vitamin B12 medicine for specific B12-related conditions.
It aims to see if the new strength helps lower a substance called tHcy in the blood.
The study involves regular blood tests and checks over two years.
Anyone with specific B12 processing issues, regardless of age or gender, may be able to join.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, doctors are looking for people who have certain health conditions related to how their body uses vitamin B12. These conditions are sometimes called "cobalamin-related remethylation disorders."

Anyone of any age, including children and adults, can potentially be considered for this study. Both men and women are welcome to take part. The exact details of who can join will depend on a medical assessment by the study doctors to make sure it's the right fit for each individual.

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.

Do I have a health condition where my body struggles to use vitamin B12 properly?
Am I comfortable with regular clinic visits and blood tests over two years?
Am I able to commit to the study schedule for up to 24 months?
Have I discussed this study with my current doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication, which is an experimental strength of hydroxocobalamin. To see how well it's working, you would have blood tests at the very beginning of the study to measure your tHcy levels. After that, you would have follow-up visits and blood tests at 3, 6, 9, 12, 15, 18, and 24 months, which means the study involves regular checks over two years. These regular checks allow the doctors to see how your body is responding to the treatment over time. The total duration of your participation would be approximately two years.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study could be that the new strength of hydroxocobalamin might effectively reduce your tHcy levels, which could improve your health condition related to vitamin B12 deficiency. However, it's also possible that this new strength may not work for everyone, or it might cause side effects. Like all medications, there's a chance of unexpected reactions. All potential risks will be thoroughly explained to you by the study team. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time without giving a reason, and it will not affect your usual 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
Spain

Common questions

What is hydroxocobalamin?

Hydroxocobalamin is a specific type of vitamin B12 that doctors sometimes use to treat people who have trouble with their body using vitamin B12 properly.

What are 'cobalamin-related remethylation disorders'?

These are health conditions where your body has difficulty processing vitamin B12 (also known as cobalamin) in a certain way, which can affect your health.

What is tHcy and why is it being measured?

tHcy (total homocysteine) is a substance in your blood. High levels can sometimes indicate that your body isn't using vitamin B12 efficiently. Measuring it helps doctors see if the treatment is working.

Will I know if I'm getting the new strength or the usual treatment?

This study is designed to compare treatments. Sometimes, participants don't know which treatment they are receiving until after the study is over, to keep the results fair. The study team will explain this to you.

How often will I need to visit the clinic?

You would have visits for blood tests at the beginning, and then at 3, 6, 9, 12, 15, 18, and 24 months over a two-year period.