Glutamine Supplementation in Cystic Fibrosis

Phase 2

Completed

• Conditions: Cystic Fibrosis; Immune Function
• Interventions: Dietary Supplement: Glutamine; Dietary Supplement: L-alanine

• Registration Number: NCT01051999
• Lead Sponsor: Emory University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-20
• Study Start: 2010-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glutamine	Glutamine	Patients randomized to the glutamine arm will receive 0.7g/kg of oral glutamine powder per day
Placebo	L-alanine	Patients randomized to the placebo arm will receive 0.7g/kg of oral isonitrogenous L-alanine powder per day

Primary Outcome Measures

Name	Time	Method
Percent increase in plasma glutamine and glutathione redox levels measured at weeks 0, 4, 8, and 12.	12 weeks

Trial Locations

Locations (1)

Emory University; 🇺🇸 Atlanta, Georgia, United States