Study of LYM-X-SORB™ to Improve Fatty Acid and Choline Status in Children With CF and PI
|Cystic Fibrosis Pancreatic Insufficiency||Dietary Supplement: Lym-X-Sorb powder Dietary Supplement: Placebo powder||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Phase II Study: LYM-X-SORB™, an Organized Lipid Matrix: Fatty Acids and Choline in CF|
- Improvements in essential fatty acid (EFA) and choline status over a 12-month period. [ Time Frame: 12-month period ]
- Improvements in growth, nutritional, and pulmonary status over an 18-month period. [ Time Frame: 18-month period ]
|Study Start Date:||January 2007|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
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.
|Placebo Comparator: 2||
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.
Fat malabsorption is common in individuals with cystic fibrosis (CF) and pancreatic insufficiency (PI). This places them at risk for caloric, essential fatty acid, and choline deficiency, which may in turn, lead to growth failure and a poorer clinical course. The purpose of this research study is to find whether or not taking LYM-X-SORB™ over an 18-month period, every day, will correct the problem people with CF and PI have with absorbing fat and choline. Participation will help CF doctors and other healthcare professionals learn more about the potential benefits of LYM-X-SORB™ to children and adolescents with CF and PI. These benefits may include better absorption of fat, better choline status, better growth in height, weight, muscle and bone, better lungs, and improvement of health status.
The study will enroll a total of 78 participants from Children's Hospital of Philadelphia (CHOP) and from several other Cystic Fibrosis Centers. One half of the participants will be randomly picked to receive the active powder with the LYM-X-SORB™ supplement and one half will receive a placebo (with no active supplement).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00406536
|United States, Pennsylvania|
|Children's Hospital of Philadelphia (CHOP)|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Walter A. Shaw, PhD||Avanti Polar Lipids, Inc.|
|Principal Investigator:||Virginia A. Stallings, MD||Children's Hospital of Philadelphia|