L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics (SANDIA)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01715844 |
Recruitment Status :
Completed
First Posted : October 29, 2012
Last Update Posted : July 2, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Dietary Supplement: L-citrulline | Phase 1 |
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 |
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 |
- 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
- 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01715844
United States, Pennsylvania | |
Asthma Institute, University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Fernando Holguin, MD MPH | University of Pittsburgh |
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 Key Record Dates |
Last Update Posted: | July 2, 2017 |
Last Verified: | June 2017 |
L-citrulline ADMA Asthma Obesity |
Overweight Body Weight |