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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Fernando Holguin, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT01715844

First received: October 16, 2012

Last updated: January 6, 2016

Last verified: January 2016

History of Changes

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

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


Enrollment:	10
Study Start Date:	September 2013
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	June 2016 (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 (Adult, Senior)
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

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: NCT01715844

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


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:	January 6, 2016
Health Authority:	United States: Internal University of Pittsburgh DSMB

Keywords provided by University of Pittsburgh:


L-citrulline ADMA Asthma Obesity

Additional relevant MeSH terms:


Overweight Body Weight Signs and Symptoms

ClinicalTrials.gov processed this record on September 23, 2016

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