AsthmaPhase 1SANDIANCT01715844
L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics
A Phase 1 study testing L-citrulline in people with Asthma, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- L-citrulline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2013to 1 Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Asthma Institute, University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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
- Conditions
- Asthma
- Being tested
- L-citrulline
- Keywords
- L-citrulline, ADMA, Asthma, Obesity
- Medical subject headings
- Asthma, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-citrullineDietary supplement
Also called L-citrulline 3 gr efervescent powder
Patients will take 3-gr of L-citrulline/day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| L-citrulline | Active comparator | 3-gr/day of L-citrulline effervescent powder mix Receives: Dietary Supplement: L-citrulline |
| Placebo | Placebo comparator | 3 gr of Placebo/day matching L-citrulline effervescent powder Receives: Dietary Supplement: L-citrulline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled nitric oxide
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
Measured: 1 week
Secondary outcomes (1)
Sputum and plasma L-arginine/ADMA levels
This outcome compares the pre to post L-citrulline supplementation changes in sputum and plasma L-arginine/ADMA
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study start7 Sep 2013
- Primary completion1 Jun 2016
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Holguin, University of Pittsburgh
- Investigators
- Fernando Holguin, MD MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715844
- Sponsor's protocol ID
- L-citrulline Asthma
- Acronym
- SANDIA
- Status last verified
- Jun 2017
- First submitted
- 16 Oct 2012
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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):e131733. doi: 10.1172/jci.insight.131733.
PubMed 31714895
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics
- ClinicalTrials.gov ID
- NCT01715844
- Acronym / sponsor ID
- SANDIA / L-citrulline Asthma
- Conditions
- Asthma
- Keywords
- L-citrulline, ADMA, Asthma, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 7 Sep 2013 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-citrulline | Active comparator | Dietary Supplement: L-citrulline3-gr/day of L-citrulline effervescent powder mix |
| Placebo | Placebo comparator | Dietary Supplement: L-citrulline3 gr of Placebo/day matching L-citrulline effervescent powder |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-citrullineAlso: L-citrulline 3 gr efervescent powderPatients will take 3-gr of L-citrulline/day for 7 days | Dietary supplement | L-citrulline, Placebo |
Primary outcome
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 secondary outcome
Sputum and plasma L-arginine/ADMA levels
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Derived from this study: PubMed 31714895Holguin 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):e131733. doi: 10.1172/jci.insight.131733.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Holguin, MD MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing L-citrulline in people with Asthma, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exhaled nitric oxide (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01715844, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.