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Asthma L-Citrulline Pilot Study (ALPS)

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.
 
ClinicalTrials.gov Identifier: NCT02943161
Recruitment Status : Completed
First Posted : October 24, 2016
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
This study will evaluate whether treatment with L-citrulline, which is an amino acid found in some foods, can increase levels of L-arginine and thereby restore the concentration of nitric oxide (NO) in the airways.

Condition or disease Intervention/treatment Phase
Asthma Dietary Supplement: L-Citrulline Not Applicable

Detailed Description:
Research has shown that some obese asthmatics have a metabolic imbalance in which L-arginine levels are reduced. L-arginine is an amino acid that is used to make NO, a gas that is normally made in the bronchi and ensures that the lungs function properly. In this pilot study subjects with asthma that have an increased body mass index compatible with being obese, will be invited to participate in a short open-label treatment with 15g/day of L-citrulline for two weeks. Study participants will be asked to do lung function testing and donate blood before and after taking the supplement. L-citrulline is safe and well tolerated and has been used at much higher doses without significant side effects.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Asthma L-Citrulline Pilot Study
Actual Study Start Date : April 5, 2017
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: L-Citrulline
In this pilot study subjects with asthma that have an increased body mass index compatible with being obese, will be invited to participate in a short open-label treatment with 15g/day of L-citrulline for two weeks. Study participants will be asked to do lung function testing and donate blood before and after taking the supplement. L-citrulline is safe and well tolerated and has been used at much higher doses without significant side effects.
 Dietary Supplement: L-Citrulline
The purpose of this study is to see if citrulline supplementation will restore NO levels and lung function in subjects with asthma.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Exhaled Nitric Oxide (eNO) [ Time Frame: 2 weeks or 14 days ]
    Change in eNO levels before and after treatment with open label L-citrulline at 15g/day


Secondary Outcome Measures :
  1. Change in Plasma L-arginine/ADMA Ratio [ Time Frame: 2 weeks or 14 days ]
    Change in L-arginine/ADMA before and after 2 weeks of L-citrulline at 15g/day


Other Outcome Measures:
  1. Change in Asthma Control Score [ Time Frame: 2 weeks or 14 days ]
    Change in asthma control scores (ACQ)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adequate completion of informed consent process with written documentation
  • Male and female patients, 18 - 70 years old, inclusive
  • Physician diagnosis of asthma (for medical records, ICD 10 coding for physician's diagnosis)
  • All racial/ethnic backgrounds may participate
  • BMI ≥ 30
  • Treatment of controller asthma medication(s) ≥ 4 weeks
  • Smoking history ≤10 pack years and no smoking in the last year
  • V1 eNO ≤ 30ppb (may be repeated 3x during visit; lowest ppb will be kept)

Exclusion Criteria:

  • Respiratory tract infection within the 4 weeks prior to the study (may re-enroll after 4 weeks).
  • Oral or systemic corticosteroid burst (for any indication) within the 4 weeks
  • One-time doses, such as intra-articular injections into a shoulder or knee joint, require a 2-week washout.
  • Asthma-related ER visit within the previous 4 weeks of Visit 1

  • Significant concomitant medical illness, including (but not limited to)

    • Heart disease
    • Cancer
    • Uncontrolled diabetes,
  • Chronic renal failure (creatinine > 2.0) at Visit 1 (Associated with higher ADMA levels)
  • Untreated sleep apnea
  • Other chronic lung/respiratory diseases (COPD, IPF, etc.)
  • High dose inhaled steroids (> 1000 mcg/day of Fluticasone or equivalent)
  • Current statin use (statins lower ADMA levels); patients may stop statins with approval from their primary physician and enroll after a 6-week washout
  • Positive urine pregnancy test at Visit 1 or at any time during the study
  • Intolerance or allergy to L-arginine or L-citrulline
  • Concomitant use of PDE5 drugs or oral mononitrates
  • Participation in an intervention study, use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study
  • Unable or unlikely to complete study assessments in the opinion of the Investigator
  • Study intervention poses undue risk to patient in the opinion of the Investigator
  • Breastfeeding
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02943161


Locations
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United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Fernando Holguin, MD, MPH University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02943161    
Other Study ID Numbers: 16-2041
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Sharing de-identified data with co-investigators approved by the IRB and Duke University

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Obesity
L-citrulline
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases