|November 29, 2006
|January 11, 2013
|June 2012 (final data collection date for primary outcome measure)
|Improvements in essential fatty acid (EFA) and choline status over a 12-month period. [ Time Frame: 12-month period ] [ Designated as safety issue: No ]
|Improvements in essential fatty acid (EFA) and choline status over a 12-month period.
|Complete list of historical versions of study NCT00406536 on ClinicalTrials.gov Archive Site
|Improvements in growth, nutritional, and pulmonary status over an 18-month period. [ Time Frame: 18-month period ] [ Designated as safety issue: No ]
|Improvements in growth, nutritional, and pulmonary status over an 18-month period.
|Study of LYM-X-SORB™ to Improve Fatty Acid and Choline Status in Children With CF and PI
|Phase II Study: LYM-X-SORB™, an Organized Lipid Matrix: Fatty Acids and Choline in CF
|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).
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).
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
- Cystic Fibrosis
- Pancreatic Insufficiency
- 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.
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|June 2012 (final data collection date for primary outcome measure)
- 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
- 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)
|6 Years to 17 Years (Child)
|Contact information is only displayed when the study is recruiting subjects
|DK60302, R44DK060302, 2R44DK060302-02A1
|Walter A. Shaw, Ph.D, Avanti Polar Lipids, Inc.
|Avanti Polar Lipids, Inc.
|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
||Walter A. Shaw, PhD
||Avanti Polar Lipids, Inc.
||Virginia A. Stallings, MD
||Children's Hospital of Philadelphia
|Avanti Polar Lipids, Inc.