Study for Children and Teens 10 to 17 With Crohn’s Disease

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about how well vitamin D is absorbed and transformed to its active form in children and teens who are healthy compared with children and teens who have Crohn’s Disease.

Who can participate?

Children and teens 10 to 17 years old who have been diagnosed with Crohn’s Disease and are taking either Infliximab (Remicade) or Adalimumab (Humira) may be eligible to participate.

Conditions

  • Crohns Disease and Colitis
  • Gastroenterology - Digestive Tract - Stomach - Liver

What will happen in the study?

This study involves 3 study visits in a week. Here are some of the things that will happen in this study:

You and your child will come in at 8 am for a full-day visit (8 hours), after he/she fasts from the night before.

Your child will:

  • Have an IV placed in his/her arm to collect blood
  • Receive vitamin D in capsule
  • Be able to eat a provided breakfast 30 minutes after taking the vitamin D
  • Have two additional blood draws during this visit from the same IV. You may opt to not have an IV in place.

You will bring your child in for a blood draw 24 hours after completing the first visit, and then 7 days later. These two additional visits will be brief. The only restrictions are that your child should not take any vitamin D supplements or use a tanning bed during this 7-day period.

You will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.

What are the good things that can happen from this research?

Your child will not receive a medical benefit from being in this study, but the information we learn about how vitamin D works in IBD patients may help them in the future.

What are the bad things that can happen from this research?

We will discuss possible risks and discomforts with parents or guardians interested in knowing more about this study.

Will you/your child be paid to be in this research study?

Families may receive up to $200 for time and effort. Your child will be provided a small breakfast, and both you and your child will receive meal tickets for lunch on the day of the first visit.

Contact

Contact Us.Study Coordinator
513-803-2055
IBDVitaminDstudy@cchmc.org
Gastroenterology, Hepatology & Nutrition
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.Stephanie Bachi de Castro Oliveira
Gastroenterology, Hepatology & Nutrition
Cincinnati Children’s Hospital Medical Center