- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01715844
L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics (SANDIA)
June 29, 2017 updated by: Fernando Holguin, University of Pittsburgh
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Asthma Institute, University of Pittsburgh
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: L-citrulline
3-gr/day of L-citrulline effervescent powder mix
|
Patients will take 3-gr of L-citrulline/day for 7 days
Other Names:
|
Placebo Comparator: Placebo
3 gr of Placebo/day matching L-citrulline effervescent powder
|
Patients will take 3-gr of L-citrulline/day for 7 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fernando Holguin, MD MPH, University of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 7, 2013
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
October 16, 2012
First Submitted That Met QC Criteria
October 26, 2012
First Posted (Estimate)
October 29, 2012
Study Record Updates
Last Update Posted (Actual)
July 2, 2017
Last Update Submitted That Met QC Criteria
June 29, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- L-citrulline Asthma
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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