L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics (SANDIA)

This study is not yet open for participant recruitment.
Verified October 2012 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Fernando Holguin, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01715844
First received: October 16, 2012
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

In people who develop asthma after the age of 12 and who are also overweigh, there can be an increased burden of asthma symptoms, more flare-ups, and poorly-controlled asthma when compared to normal weight asthmatics. Certain factors are more abundant in the blood of individuals who are obese. One such factor is derived from the metabolism of an amino acid found in your diet, which is known as L-arginine (Amino acids are most commonly known as the building blocks of proteins, the same as the proteins found in food). This factor is called asymmetric dimethylarginine or ADMA. The balance of L-arginine to ADMA may be important to the health of subjects with asthma. The balance between L-arginine and ADMA plays an important role in producing nitric oxide (NO) in the airways. NO is normally produced in the lung and plays a major role in maintaining airways open and functioning normally. Our research has shown that in subjects with asthma who are overweight and developed asthma later in life, the combination of low L-arginine and high ADMA, may lead to lower NO levels. We are asking participants in this study to take L-citrulline, which is converted to L-arginine by your body, as a supplement for a period of one week. We anticipate that L-citrulline will restore NO levels in the airways, by increasing the ratio of L-arginine to ADMA


Condition Intervention Phase
Asthma
Dietary Supplement: L-citrulline
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Exhaled nitric oxide [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Patients will be randomized to 1 week of 3 g of L-citrulline/day vs matching placebo, The outcome is the pre to post intervention change in exhaled NO


Secondary Outcome Measures:
  • Sputum and plasma L-arginine/ADMA levels [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    This outcome compares the pre to post L-citrulline supplementation changes in sputum and plasma L-arginine/ADMA


Estimated Enrollment: 10
Study Start Date: January 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: L-citrulline
3-gr/day of L-citrulline effervescent powder mix
Dietary Supplement: L-citrulline
Patients will take 3-gr of L-citrulline/day for 7 days
Other Name: L-citrulline 3 gr efervescent powder
Placebo Comparator: Placebo
3 gr of Placebo/day matching L-citrulline effervescent powder
Dietary Supplement: L-citrulline
Patients will take 3-gr of L-citrulline/day for 7 days
Other Name: L-citrulline 3 gr efervescent powder

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients, 18-75 yrs old, from all racial/ethnic backgrounds
  • Diagnosis of asthma for >1 yr
  • BMI ≥ 30
  • Baseline pre-bronchodilator FEV1 between 60 and 90% predicted with a 12% or greater bronchodilator response to 4 puffs of albuterol
  • Smoking history <20 pack years and no smoking in the last year
  • Able to identify age of asthma onset

Exclusion Criteria:

  • Respiratory tract infection within the last 4 weeks;
  • Oral CS burst within the last 4 weeks or regular systemic CS use
  • Hospitalization within the last 3 months
  • ER visit within the 4 weeks
  • Significant or uncontrolled concomitant medical illness including (but not limited to) heart disease, cancer, diabetes
  • Current smoking or within the previous 12 months
  • Current use of statins for the past 30 days (Statins lower ADMA levels)
  • Pregnancy
  • Intolerance or allergy to L-arginine or L-citrulline
  • Phosphodiesterase inhibitors
  • Taking oral nitrates
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715844

Contacts
Contact: Fernando Holguin, MD MPH 412-692-2817 holguinf@upmc.edu
Contact: Sabrina I Malik, MPH 412-864-2915 maliks2@upmc.edu

Locations
United States, Pennsylvania
Asthma Institute, University of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Sabrina I Malik, MPH    412-864-2915      
Contact: Amanda Pietras, BS    412-864-2219      
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Fernando Holguin, MD MPH University of Pittsburgh
  More Information

No publications provided

Responsible Party: Fernando Holguin, Assistant Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01715844     History of Changes
Other Study ID Numbers: L-citrulline Asthma
Study First Received: October 16, 2012
Last Updated: October 26, 2012
Health Authority: United States: Internal University of Pittsburgh DSMB

Keywords provided by University of Pittsburgh:
L-citrulline
ADMA
Asthma
Obesity

Additional relevant MeSH terms:
Asthma
Overweight
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014