Glutamine Supplementation in Cystic Fibrosis (CFG)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Emmaus Medical, Inc.
Information provided by (Responsible Party):
Thomas R. Ziegler, MD, Emory University
ClinicalTrials.gov Identifier:
NCT01051999
First received: January 15, 2010
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Cystic Fibrosis
Immune Function
Dietary Supplement: Glutamine
Dietary Supplement: L-alanine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Glutamine Supplementation and Immunity in Adults With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Percent increase in plasma glutamine and glutathione redox levels measured at weeks 0, 4, 8, and 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2010
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051999

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

No publications provided

Responsible Party: Thomas R. Ziegler, MD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01051999     History of Changes
Other Study ID Numbers: IRB00025564
Study First Received: January 15, 2010
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Glutamine

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

ClinicalTrials.gov processed this record on August 28, 2014