PKU Dietary Management with Lophlex™ Nutritional Drink

A Study to Monitor Nutritional Status and Metabolic Control and Evaluate Compliance of Patients with Phenylketonuria (PKU) Using Lophlex Low-Volume PKU Drink

Protocol Description

The purpose of this study is to determine whether Lophlex™ low-volume nutritional drink, when taken as prescribed, supports normal nutrition and metabolic control in patients with phenylketonuria (PKU), a genetic disorder characterized by an inability of the body to utilize the essential amino acid, phenylalanine. A secondary goal is to determine if patients are more likely to take all of their formula more easily every day when Lophlex is used.

Eligibility Criteria

Subject to certain screening criteria, children age 9 and older of both genders with PKU are eligible.
Boys: Age 9 and up
Girls: Age 9 and up

Following a taste test to determine preference of flavor, participants will use Lophlex as prescribed by the clinic dietician and keep a careful log of Lophlex intake and monthly blood phenylalanine (Phe) levels over a period of 4 months. A nutritionist or nurse will call once a month for the 3 months after the first visit to review progress. At the end of 4 months, participants will return for a final examination and to fill out a questionnaire about Lophlex.
Visits: 2
Duration: 4 months

Status: Open for Enrollment

Source of Support
Nutricia North America

Primary Investigator(s)

Gerard Vockley, MD

Contact Information

To get started, please contact:
Judy Henry

Last Update
November 7, 2010
  • Increase/Decrease Text Size
  • Print This Page
Last Update
November 7, 2010