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

• ClinicalTrials.gov Identifier: NCT01715844
• Recruitment Status: Completed
• First Posted: October 29, 2012
• Last Update Posted: July 2, 2017
• Sponsor: University of Pittsburgh
• Information provided by (Responsible Party): Fernando Holguin, University of Pittsburgh

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Asthma	Dietary Supplement: L-citrulline	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics
• Actual Study Start Date: September 7, 2013
• Actual Primary Completion Date: June 1, 2016
• Actual Study Completion Date: June 1, 2017

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Exhaled nitric oxide [ Time Frame: 1 week ]
   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 :

1. Sputum and plasma L-arginine/ADMA levels [ Time Frame: 1 week ]
   This outcome compares the pre to post L-citrulline supplementation changes in sputum and plasma L-arginine/ADMA

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Pennsylvania

Asthma Institute, University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Investigators

• Principal Investigator: Fernando Holguin, MD MPH; University of Pittsburgh

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Holguin F, Grasemann H, Sharma S, Winnica D, Wasil K, Smith V, Cruse MH, Perez N, Coleman E, Scialla TJ, Que LG. L-Citrulline increases nitric oxide and improves control in obese asthmatics. JCI Insight. 2019 Dec 19;4(24). pii: 131733. doi: 10.1172/jci.insight.131733.

• Responsible Party: Fernando Holguin, Assistant Professor of Medicine, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT01715844
• Other Study ID Numbers: L-citrulline Asthma
• First Posted: October 29, 2012
• Last Update Posted: July 2, 2017
• Last Verified: June 2017

Keywords provided by Fernando Holguin, University of Pittsburgh:

L-citrulline; ADMA; Asthma; Obesity

Additional relevant MeSH terms:

Overweight; Body Weight