Trial record 1 of 1 for:    "NCT01051999"
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Glutamine Supplementation in Cystic Fibrosis (CFG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01051999
Recruitment Status : Completed
First Posted : January 20, 2010
Last Update Posted : January 14, 2015
Emmaus Medical, Inc.
Information provided by (Responsible Party):
Thomas R. Ziegler, MD, 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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Immune Function Dietary Supplement: Glutamine Dietary Supplement: L-alanine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Glutamine Supplementation and Immunity in Adults With Cystic Fibrosis
Study Start Date : February 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Glutamine
Patients randomized to the glutamine arm will receive 0.7g/kg of oral glutamine powder per day
Dietary Supplement: Glutamine
Oral glutamine powder

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

Primary Outcome Measures :
  1. Percent increase in plasma glutamine and glutathione redox levels measured at weeks 0, 4, 8, and 12. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01051999

United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Emmaus Medical, Inc.

Responsible Party: Thomas R. Ziegler, MD, Professor, Emory University Identifier: NCT01051999     History of Changes
Other Study ID Numbers: IRB00025564
First Posted: January 20, 2010    Key Record Dates
Last Update Posted: January 14, 2015
Last Verified: January 2015

Keywords provided by Thomas R. Ziegler, MD, Emory University:

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases