Calcium Study for Formula-Fed Infants
What is the purpose of this study?
The purpose of this research study is to evaluate the amount of calcium absorbed in infants fed formula
Who will be included in this study?
Healthy full term, formula- fed infants between the age of 56 to 70 days old (approximately two-months old)
What is involved?
This study lasts for approximately 16 days and includes 2 visits. The following is a list of procedures that will take place during the study:
- Study procedures reviewed and consent form signed, if you qualify
- Randomized to receive either a current infant formula on the market or Study formula that is not available on market
- Drink only the assigned formula for 14 days
- An overnight stay at CCHMC for 24 hour urine collection (urine bags)
- Blood draw of less then a teaspoon
- At the same time of blood draw, (one stick for both) give stable calcium isotope (which is a form of calcium with special features that allow it to be traced without the use of radioactivity)
- Drink four oz. of formula that contains calcium isotope tracer
What are the benefits?
Your child may receive no direct benefit from participating in this study. The information learned from this research study may help the investigators better understand calcium absorption in infants from formula and breast milk.
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. It goes over all of the procedures, the risks, the benefits, the compensation, 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/guardian has signed this form and, if of age, the child has given at minimum his/her verbal agreement.
What are the risks?
There is a minimal risk of bleeding, bruising and/or pain at the site of the blood draw. These risks will be lessened by using doctors and nurses with experience in drawing blood on infants. There are no known risks to the stable Calcium isotopes. It is possible that you may not tolerate the formula that is provided. This could result in an upset stomach or rash.
There may be unknown or unforeseen risks associated with study participation.
What is the compensation?
You will receive $30 for each of two study visits and $100 for an overnight visit for a total of $160 for completion of the entire study. Participants will also receive a three-month supply of infant formula, at no charge, for completing the study.
Who should I contact for more information?
Kathleen Lake, MSW, LISW
Cincinnati Children's Hospital Medical Center
Division of Gastroenterology, Hepatology & Nutrition
3333 Burnet Avenue, MLC 2010
Cincinnati, OH 45229-3039
Phone: (513) 636-0572
kathleen.lake@cchmc.org
