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Learn about the THRIVE-3 Clinical Study

If you or your loved one is on parenteral nutrition (PN), you may be able to join this study.

What is the goal of this clinical study?

The goal of this clinical study is to learn whether adding intravenous (IV) Choline Chloride to parenteral nutrition (PN) can help people ages 12 years and older living with intestinal failure. In past studies, about 80% of people on long-term PN did not have enough choline, an essential nutrient, in their blood. This study will look at whether adding IV Choline Chloride to regular PN infusions can raise choline levels in the blood.

This study has 2 Parts, and each has a different goal.

The main goals are:

  • Part 1: To learn about the safety of different doses (amounts) of IV Choline Chloride and what happens to it in the body. Researchers will use the results from Part 1 to choose doses of IV Choline Chloride to use in Part 2.

  • Part 2: To learn how well IV Choline Chloride works to raise choline levels and learn more about its safety.

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What is a clinical study?

A clinical study is research done with people to learn more about a possible treatment, called a study drug. Clinical studies help researchers understand whether a study drug is safe to use and how well it may work for certain conditions.

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What is IV Choline Chloride?

IV Choline Chloride is a study drug. It is liquid choline given through a vein (intravenously) with PN infusions. It can be added directly to the PN bag or given in a separate saline bag.   

Because people on PN may not be able to raise their level of choline by taking a pill or eating food, adding choline to their PN may be the best option. Past studies of people on PN showed that giving choline through an IV infusion led to higher levels of choline in the blood and fewer signs of problems caused by low choline levels. 

Could I join this study?

You (or your loved one) may be able to join this study if you:

  • Are 12 years old or older

  • Have intestinal failure

  • Have used PN at least 3 times a week for at least 6 months 

  • Are not taking medicines that affect your liver or certain supplements

  • Do not have certain other health conditions

There are other criteria that you must meet. If you are interested in joining, the study staff will do tests to make sure you can be in the study. 

See if you can join
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What will happen during this study?

You will be in either Part 1 or Part 2 of this study, depending on when you join the study. You will be in the study for about a year and a half and have up to:

  • 12 visits to the study site, and 

  • 5 visits at your home 

You may have more visits, if needed for study staff to check your health.

Here is what will happen during the study:​

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Study staff will talk with you about the study. If you choose to join, you will sign an informed consent form.

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Study staff will ask questions and do some tests to be sure you can be in this study. This is called screening.

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Study staff will assign you to a study treatment group. They will train you on how to add your assigned study drug to your PN at home. You will have to keep a diary and take photos when you prepare and give the study drug.

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You will have tests, including:

  • Physical exams

  • Blood and urine tests

  • Imaging tests, such as MRIs of your liver

  • Heart tests called ECGs

  • Questions about your diet 

Will I get IV Choline Chloride in the study?

Researchers plan to give everyone in this study IV Choline Chloride at some point. When you get it and for how long depends on which Part of the study you are in.

Part 1

If you are in Part 1, you will be assigned by chance to 1 of 3 doses (amounts) of IV Choline Chloride.

After 2 months your dose may be changed based on early study results.

Part 2

If you are in Part 2, you will be assigned by chance to one of these study treatment groups:

  • IV Choline Chloride at 1 of 2 doses, or 

  • Placebo, which will look like IV Choline Chloride, but will not have choline in it. Researchers use a placebo to better understand if IV Choline Chloride works or not. 

In Part 2, you will not know if you are getting IV Choline Chloride or placebo for the first 6 months. After 6 months:

  • If you were getting IV Choline Chloride, you will continue to receive IV Choline Chloride for the rest of the study

  • If you were getting placebo, you will be assigned by chance to 1 of the 2 doses of IV Choline Chloride for the rest of the study

What are the possible benefits of joining this study?

Taking part in this study may or may not raise your blood choline level. You may or may not have benefits from choline, including on your liver and brain health, mood, and muscle control.

You may help researchers learn about a possible source of choline, an essential nutrient, for people with intestinal failure who use PN in the future.

What are the possible risks of joining this study?

Based on past studies, possible side effects of IV Choline Chloride could include:

  • More sweat, saliva, and tears than usual

  • Stomach cramps, feeling sick to your stomach, throwing up, and diarrhea    

  • Feeling dizzy

This study includes many tests, and some of them have risks. These include:

  • Giving blood samples, which may cause pain or a bruise where the needle goes into your skin, fainting, and, in rare cases, infection

  • Heart tests (ECGs), which may cause redness or irritation where patches are stuck on your skin

  • Imaging tests of your liver, which include certain types of MRI. MRIs can be loud and require you to lie still on the scan table in an enclosed space, which could make you feel anxious. 

Will I have any costs or be paid?

You will not have any costs to be in the study. 

You may be paid back (reimbursed) for certain costs related to the study, such as time and travel costs for study visits.

Where are the study sites?

This study is taking place at sites in the United States and certain European countries shown in the maps below:

Who do I contact to learn more about this study?

To see if you or your loved one can join, answer some questions at [link to screener].

It may also be helpful to speak with your doctor, as well as family or friends, to decide if this study feels right for you or a loved one.

To learn more about this study, you can visit the study pages at:

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