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

This study has been completed.

Sponsor:

Collaborator:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Information provided by (Responsible Party):

Walter A. Shaw, Ph.D, Avanti Polar Lipids, Inc.

ClinicalTrials.gov Identifier:

NCT00406536

First received: November 29, 2006

Last updated: January 11, 2013

Last verified: January 2013

History of Changes

Purpose

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	Intervention	Phase
Cystic Fibrosis Pancreatic Insufficiency	Dietary Supplement: Lym-X-Sorb powder Dietary Supplement: Placebo powder	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care
Official Title:	Phase II Study: LYM-X-SORB™, an Organized Lipid Matrix: Fatty Acids and Choline in CF

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Further study details as provided by Avanti Polar Lipids, Inc.:

Primary Outcome Measures:

Improvements in essential fatty acid (EFA) and choline status over a 12-month period. [ Time Frame: 12-month period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvements in growth, nutritional, and pulmonary status over an 18-month period. [ Time Frame: 18-month period ] [ Designated as safety issue: No ]

Enrollment:	110
Study Start Date:	January 2007
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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).

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406536

Locations

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)

Investigators

Principal Investigator:	Walter A. Shaw, PhD	Avanti Polar Lipids, Inc.
Principal Investigator:	Virginia A. Stallings, MD	Children's Hospital of Philadelphia

More Information

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Responsible Party:	Walter A. Shaw, Ph.D, Principle Investigator, Avanti Polar Lipids, Inc.
ClinicalTrials.gov Identifier:	NCT00406536 History of Changes
Other Study ID Numbers:	DK60302, R44DK060302, 2 R44 DK60302 02A1
Study First Received:	November 29, 2006
Last Updated:	January 11, 2013
Health Authority:	United States: Federal Government United States: Institutional Review Board

Keywords provided by Avanti Polar Lipids, Inc.:

Cystic Fibrosis
Pancreatic Insufficiency
LYM-X-SORB™
LXS

Additional relevant MeSH terms:

Cystic Fibrosis
Fibrosis
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases

Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013

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