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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00406536
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : January 14, 2013
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Walter A. Shaw, Ph.D, Avanti Polar Lipids, Inc.

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 adolescents with Cystic Fibrosis (CF) and pancreatic insufficiency (PI).

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Pancreatic Insufficiency Dietary Supplement: Lym-X-Sorb powder Dietary Supplement: Placebo powder Phase 2

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 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
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
Study Start Date : January 2007
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Improvements in essential fatty acid (EFA) and choline status over a 12-month period. [ Time Frame: 12-month period ]

Secondary Outcome Measures :
  1. Improvements in growth, nutritional, and pulmonary status over an 18-month period. [ Time Frame: 18-month period ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00406536

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United States, Pennsylvania
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Avanti Polar Lipids, Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Walter A. Shaw, PhD Avanti Polar Lipids, Inc.
Principal Investigator: Virginia A. Stallings, MD Children's Hospital of Philadelphia

Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Walter A. Shaw, Ph.D, Principle Investigator, Avanti Polar Lipids, Inc. Identifier: NCT00406536    
Other Study ID Numbers: DK60302
R44DK060302 ( U.S. NIH Grant/Contract )
2R44DK060302-02A1 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: January 14, 2013
Last Verified: January 2013
Keywords provided by Walter A. Shaw, Ph.D, Avanti Polar Lipids, Inc.:
Cystic Fibrosis
Pancreatic Insufficiency
Additional relevant MeSH terms:
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Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases