Glutamine Supplementation in Cystic Fibrosis

NCT ID: NCT01051999

Last Updated: 2015-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-02-28

Brief Summary

Patients with cystic fibrosis develop frequent and potentially life-threatening lung infections. Recent studies suggest that the nutrient "glutamine" may help the body fight off infection. Glutamine is an amino acid; a type of nutrient the body requires to build muscle. It is one of the building blocks of protein. During an illness, blood levels of glutamine tend to be lower than normal. Also, many patients with cystic fibrosis have difficulty getting normal levels of nutrients from food. The aim of this study is to see if patients with cystic fibrosis have low levels of glutamine when they experience an infection, and whether a dietary glutamine supplement taken daily for three months can raise these levels. We also want to see if this supplement can improve other blood markers of immunity (the body's ability to defend itself from infection). We hope to enroll 40 people with cystic fibrosis who experience a lung infection, over a one year period, into this study.

Conditions

Cystic Fibrosis; Immune Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Glutamine

Patients randomized to the glutamine arm will receive 0.7g/kg of oral glutamine powder per day

Group Type: EXPERIMENTAL

Glutamine

Intervention Type: DIETARY_SUPPLEMENT

Oral glutamine powder

Placebo

Patients randomized to the placebo arm will receive 0.7g/kg of oral isonitrogenous L-alanine powder per day

Group Type: PLACEBO_COMPARATOR

L-alanine

Intervention Type: DIETARY_SUPPLEMENT

L-alanine oral powder

Interventions

Glutamine

Oral glutamine powder

Intervention Type: DIETARY_SUPPLEMENT

L-alanine

L-alanine oral powder

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Adult patients (≥ 18 years of age) with cystic fibrosis who give informed consent
• Patients must have a clinically diagnosed pulmonary exacerbation at time of enrollment, characterized by clinical requirement for oral or intravenous antibiotics associated with pulmonary symptoms such as increased cough or decreased forced expiratory volumes (FEV1)
• Participants must agree to provide phlebotomy samples and complete all study protocol at presentation and at return visits

Exclusion Criteria

• Any patients taking specific glutamine supplements within 30 days of enrollment
• Pregnant or lactating women
• Patients involved in any other research protocol involving intake of a study drug, in the last 60 days.
• Patients who are chronically immunosuppressed due to drugs or immunosuppressive illness other than CF (e.g. HIV/AIDS, chronic autoimmune disease)
• Patients receiving hemodialysis or with creatinine >2.5mg/dL
• Patients with liver failure from any cause
• Patients with a history of cancer within the past 12 months or currently receiving anti-neoplastic therapy.
• Patients with a history of seizures

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emmaus Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Thomas R. Ziegler, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00025564

Identifier Type: -

Identifier Source: org_study_id