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Glutamine Supplementation in Cystic Fibrosis (CFG)

Primary Purpose

Cystic Fibrosis, Immune Function

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Glutamine
L-alanine
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cystic Fibrosis focused on measuring Glutamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Glutamine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 15, 2010
Last Updated
January 13, 2015
Sponsor
Emory University
Collaborators
Emmaus Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01051999
Brief Title
Glutamine Supplementation in Cystic Fibrosis
Acronym
CFG
Official Title
Glutamine Supplementation and Immunity in Adults With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Emmaus Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Immune Function
Keywords
Glutamine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glutamine
Arm Type
Experimental
Arm Description
Patients randomized to the glutamine arm will receive 0.7g/kg of oral glutamine powder per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients randomized to the placebo arm will receive 0.7g/kg of oral isonitrogenous L-alanine powder per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Glutamine
Intervention Description
Oral glutamine powder
Intervention Type
Dietary Supplement
Intervention Name(s)
L-alanine
Intervention Description
L-alanine oral powder
Primary Outcome Measure Information:
Title
Percent increase in plasma glutamine and glutathione redox levels measured at weeks 0, 4, 8, and 12.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

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Glutamine Supplementation in Cystic Fibrosis

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