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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis, Pancreatic Insufficiency

In brief

The purpose of this phase II research study is to evaluate the effectiveness of the next generation LYM-X-SORB™ in improving the essential fatty acid (EFA) and choline status for children and adolescents with Cystic Fibrosis (CF) and pancreatic insufficiency (PI).

Key facts

Study ID

NCT00406536

Run by

Avanti Polar Lipids, Inc.

People needed

110

Starts

2007-01-01

Expected to finish

2012-06-01

Last updated by the study team

2013-01-14

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed as having cystic fibrosis (CF) with pancreatic insufficiency (PI)
• Subjects aged 6 to 17 years of age
• In usual state of good health
• Family and subject commitment to the 18-month study protocol
• Fecal elastase < 15µg/g stool

You may not qualify if…

• Forced expiratory volume at one second, % predicted (FEV1) < 40% predicted
• Other chronic health conditions that may affect GI absorption, growth, dietary intake, nutritional status
• Liver disease, lung transplant, celiac disease, allergy/intolerance to wheat/gluten, pregnant
• Participation in another CF nutrition-related intervention study
• Regular intake of fatty acids (i.e., fish oils) or choline nutritional supplements
• Home parenteral lipid administration (i.e., intralipids)

Where it is running

• Children's Hospital of Philadelphia (CHOP) — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.