Research Study for Children and Teens 6-16 Years Old With Down Syndrome
What is the purpose of this study?
Cincinnati Children's is conducting a research study to evaluate the effects of LiQ-Nol, a natural antioxidant administered as a highly concentrated liquid form, in children with Down Syndrome.
Who will be included in this study?
Children, adolescents and teenagers 6-16 years old with Down Syndrome may be eligible to participate.
What is involved?
The study lasts for 9 months and includes 3 visits. The following is a list of procedures that will take place during the study:
- The study drug (LiQ-Nol) will be given by mouth 2X day for 6 months
- Three visits spaced over 6 months consisting of a speech evaluation, behavioral questionnaires, study drug education and a blood draw
- A behavioral questionnaire called the Teacher Report Form will be sent out to the child's teacher after each visit to be filled out and returned
- A follow-up questionnaire will be mailed out 3 months after the last visit, to be filled out and returned
What are the benefits?
Your child may receive no direct benefit from participating in this study. The greatest benefit is that your child may be contributing to research that helps other children. Research studies are essential in finding new and improved treatments and diagnostic tools.
Will I get all the facts about the study?
Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent or guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.
What are the risks?
The risks of participation include discomfort and possible bruising or infection from the blood draw. There are no known severe adverse effects from LiQ-Nol, but side effects could occur because a higher than normal dosage for children is being given. (Much higher doses have been given to adults, however, and serious adverse effects were not reported.) A detailed list of possible side effects will be provided to those parents or guardians interested in knowing more about this study.
What is the pay?
Participants will receive $15 for each of the three visits.
Who should I contact for more information?
Stephanie Hotze
Cincinnati Children's Hospital Medical Center
The Jane and Richard Thomas Center for Down Syndrome
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-3881
stephanie.hotze@cchmc.org
