Glutamine Supplementation in Cystic Fibrosis

NCT01051999 | Completed Phase 2

• 1 other identifier: IRB00025564
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Keywords

Glutamine

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Study Arms (2)

Glutamine

EXPERIMENTAL

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

Dietary Supplement: Glutamine

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: L-alanine

Interventions

Glutamine DIETARY_SUPPLEMENT

Oral glutamine powder

Glutamine

L-alanine DIETARY_SUPPLEMENT

L-alanine oral powder

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Emmaus Medical, Inc.: collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Glutamine; Alanine

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2010
• First Posted: January 20, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

US (1)