Study of LYM-X-SORB™ to Improve Fatty Acid and Choline Status in Children With CF and PI

PHASE2CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

June 30, 2012

Study Completion Date

June 30, 2012

Conditions
Cystic FibrosisPancreatic Insufficiency
Interventions
DIETARY_SUPPLEMENT

Lym-X-Sorb powder

Lym-X-Sorb is an organized matrix of lyso phosphatidylcholine (LPC), free fatty acid (FFA) and monoglyceride formulated at 20wt% with flour and sugar. A dosage contains 32 grams of powder and is consumed with food twice a day (6 to 11.9 years old) or three times per day (12 to 17.9 years old) for 18 months.

DIETARY_SUPPLEMENT

Placebo powder

The placebo is composed of soybean oil, sunflower oil, fully hydrogenated cottonseed oil and flax seed oil dispersed at 16wt% on flour and sugar. The placebo is \>99% triglycerides with no trans fatty acids. The fatty acid composition and caloric content is designed to match the active supplement (Lym-X-Sorb). A dosage contains 32 grams of powder and is consumed with food twice a day (6 to 11.9 years old) or three times per day (12 to 17.9 years old) for 18 months.

Trial Locations (1)

19104

Children's Hospital of Philadelphia (CHOP), Philadelphia

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

Avanti Polar Lipids, Inc.

INDUSTRY

NCT00406536 - Study of LYM-X-SORB™ to Improve Fatty Acid and Choline Status in Children With CF and PI | Biotech Hunter | Biotech Hunter