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

Sponsor

Avanti Polar Lipids, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00406536

Collaborator

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

110

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

Study Design

Study Type:

Interventional

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 :

Jan 1, 2007

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Improvements in essential fatty acid (EFA) and choline status over a 12-month period. [12-month period]

Secondary Outcome Measures

Improvements in growth, nutritional, and pulmonary status over an 18-month period. [18-month period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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