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

NCT ID: NCT00406536

Last Updated: 2013-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-06-30

Brief Summary

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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).

Detailed Description

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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).

Conditions

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Cystic Fibrosis Pancreatic Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Lym-X-Sorb powder

Intervention Type DIETARY_SUPPLEMENT

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.

2

Group Type PLACEBO_COMPARATOR

Placebo powder

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Avanti Polar Lipids, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Walter A. Shaw, Ph.D

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walter A. Shaw, PhD

Role: PRINCIPAL_INVESTIGATOR

Avanti Polar Lipids, Inc.

Virginia A. Stallings, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R44DK060302

Identifier Type: NIH

Identifier Source: secondary_id

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2R44DK060302-02A1

Identifier Type: NIH

Identifier Source: secondary_id

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DK60302

Identifier Type: -

Identifier Source: org_study_id

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