Status:
COMPLETED
Study of LYM-X-SORB™ to Improve Fatty Acid and Choline Status in Children With CF and PI
Lead Sponsor:
Avanti Polar Lipids, Inc.
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Cystic Fibrosis
Pancreatic Insufficiency
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
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 adolesce...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00406536
Start Date
January 1 2007
End Date
June 1 2012
Last Update
January 14 2013
Active Locations (1)
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1
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States, 19104