Q: How many participants will be in your study?
A: Our goal is 200 in 2010, and 1,000 by the end of 2012.
Q: What do you expect to see as a result of this study?
A: A decrease in infant mortality rates, and faster than expected achievement of growth and developmental milestones.
Q: Is there any research backing up what you are studying?
A: Yes. This study builds on already established research. You can view some of it here (create link to page)
Q: Does this study have a formal name?
A: Yes. The current name of the study is “The Effects of Trace Mineral Supplemenation on the Growth of the Premature Neonate.”
Q: How long will the study run?
A: Between three and five years. Each child entered into the study will be followed for 36 months, which is why there is a range of time.
Q: Do you have any FDA approvals?
A: No, the compounds being used are "over the counter supplements" and as such, not under the governance of the FDA. Appropriate documentation as to content via essay has been obtained from each company providing product.
Q: Why are you testing two different compounds?
A: To determine if there are any measurable differences in results between each of them and the control group; also, one is "trace minerals only" while the other is "trace minerals plus a little extra."
Q: What are the outcome that will be measured / how often?
A: Weight, Length, Head Circumference; also, standard developmental milestone checklist, with medical history (ongoing/updated); all assessments to be performed by either home visiting pediatric nurses -or- filled out by the participant's pediatrician during weeks when infant sees pediatrician; schedule: once a week for 16 weeks; bi-weekly for 2-4 months (depending on age at entrance into study); once a month thereafter for a total of 36 months
Q: Are there target cofactors within specific metabolic pathways targeted?
A: No. This is a "pilot/preliminary" study to determine if this nutritional approach (based on pg 631 of the Textbook of Pediatric Gastroenterology & Nutrition, among other sources) can duplicate the results experienced by the twins.
Q: When does this start?
A: Target dates are to begin participant recruitment in December, 2009/January, 2010.
