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

Cystic Fibrosis Clinical Trial

Official title:

Phase II Study: LYM-X-SORB™, an Organized Lipid Matrix: Fatty Acids and Choline in CF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00406536
• Other study ID #: DK60302
• Secondary ID: R44DK0603022R44D
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2006
• Last updated: January 11, 2013
• Start date: January 2007
• Est. completion date: June 2012

Study information

• Verified date: January 2013
• Source: Avanti Polar Lipids, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cystic Fibrosis
• Exocrine Pancreatic Insufficiency
• Pancreatic Insufficiency

Intervention

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 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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia (CHOP)	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Avanti Polar Lipids, Inc.	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

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* Note: There are 158 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvements in essential fatty acid (EFA) and choline status over a 12-month period.		12-month period	No
Secondary	Improvements in growth, nutritional, and pulmonary status over an 18-month period.		18-month period	No