| EARLY Trial | UCSF School of Nursing |
| Endothelial Assessment of Risk from Lipids in Youth | University of California, San Francisco |
What is this research project studying?
This research study is studying the effects a National Cholesterol Education Program (NCEP) Step II diet (low fat, low cholesterol) and dietary supplements/vitamins would make to help improve the function of blood vessels in children (ages 8-21) who have high cholesterol. The study will also be looking at whether the 2 treatments will help to improve other factors, such as cholesterol levels (LDL, HDL, etc.), nitric oxide (a molecule that promotes blood vessel relaxation), and other related factors.
What is involved if we decide to participate?
Participants will be in the study program for a period of 6 months. Participants will have various physical measurements taken, such as a physical exam, height, weight, temperature, blood pressure, a ultrasound of their blood vessels, skin-fold measurements, and a blood draw to measure their blood cholesterol levels. Some of these measurements will be repeated at every visit so that the any change in their physical measurements can be measured as the participants go through the various treatments. Finally, participants along with their parents will go through nutritional counseling and work with a certified nutritionist to learn about eating a low fat, low cholesterol diet.
Are the supplements safe to take? Are there any side effects? What kind of research has been done so far about them?
Yes, they are very safe. As a matter of fact, the vitamins C and E that the participants will be taking can also be obtained in fruits, vegetables, whole grains and nuts but you would need to eat a lot every day to obtain the amount the supplements provide. The omega-3 fatty acid supplements are also very safe and have been shown to prevent heart disease in many large studies all over the world.. They have even been recently recommended by the American Heart Association to improve cardiovascular health.
How many days and hours are involved?
Enrollment in the study is for a 6-month period, in which participants will meet once every 6 weeks for a total of 6 visits. For each visit, they will meet for half a day between 8:00 a.m. until 12:00 noon at the UCSF Moffitt Hospital (505 Parnassus Ave.) in the Pediatric Clinical Research Center.
How much school would be missed?
Participants will miss a total of 6 days of school during the 6-month enrollment in the study. Most parents and participants in the past have chosen to miss the entire day of school when a visit occurs, but visits last only half a day (between 8:00 a.m. · 12:00) so possibly only six half-days of school will be missed.
Do you have to show up for all the visits in order to participate?
Yes, participants in the study are expected to make all 6 visits. Since physical measurements are taken at most of the visits, it is important for the researchers to be able to study the changes that occur over a period of time. If a participant has missed a visit, the researchers cannot take any physical measurements, and therefore, the data that has been collected so far will be incomplete and not usable for the study.
What are the incentives for participating?
Since all the participants in this study have high cholesterol (one of the criteria to be able to participate in this study is having high cholesterol), one of the major incentives is finding out if changing your diet will help to improve your cardiovascular health, such as lowering your cholesterol levels and improving the function of your blood vessels. Participants and their parents have an opportunity to work with a nutritionist to learn about eating a heart healthy diet and know more about how to choose the right foods to eat for their kids. Participants will also experience taking supplements, or vitamins, to see whether any of these have positive improvement on your cardiovascular health.
Since children with high cholesterol cannot take cholesterol-lowering medications like adults do (no research can be done on whether cholesterol-lowering medications will affect hormonal levels of growing children), then another incentive to participating is finding out what kind of vitamins are good to take to help in lowering children's cholesterol levels.
Are there any costs to participate?
There are no costs to participate. Participants are able to experience free medical treatment with all the physical measurements and nutritional counseling included in the study. The only cost for the participants will be their time spent in the study and their travel to the UCSF hospital.
Is there any financial reimbursement?
There is no financial reimbursement for time or travel spent for this study. However, a parking sticker/validation will be provided for free parking on the visit days.
Can I see everything in writing?
Yes, after speaking with one of our research team members (please check the Contact Us page for contacting information), you are welcomed to see the details of this study outlined in writing. Documentation can be sent to your home residence or pediatrician's office, so that you can discuss the positive aspects of participating for your child.
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For more information, contact:
marguerite.engler@nursing.ucsf.edu
Version 1.7 · 17 Jan. 2006