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L-citrulline for Asthma (SANDIA Trial)

Phase 2
Recruiting
Led By Fernando Holguin, MD, MPH
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Physician diagnosis of asthma
Age of asthma onset (diagnosis) >/= 12 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 32 weeks
Awards & highlights

SANDIA Trial Summary

This trial is testing whether L-citrulline, an L-arginine donor, can improve the asthma control and lung function in obese late onset asthmatics by increasing the L-arginine/ADMA ratio, FeNO levels, and reducing bronchoconstriction and lung inflammation.

Who is the study for?
This trial is for adults with asthma that started after childhood, who are obese (BMI >= 30), and have a history of poor response to inhaled steroids. They should be on regular asthma medication but not have had an exacerbation or used systemic corticosteroids in the last month. Smokers or those with recent lung infections aren't eligible.Check my eligibility
What is being tested?
The study tests if L-citrulline improves asthma control and lung function in obese adults with late-onset asthma. Participants will take either L-citrulline or a placebo over two 8-week periods, separated by a washout period, to compare effects on their condition.See study design
What are the potential side effects?
Potential side effects may include discomfort at the supplement intake site, gastrointestinal issues like upset stomach or diarrhea, and changes in blood pressure. Allergic reactions could occur but are less common.

SANDIA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with asthma by a doctor.
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I was diagnosed with asthma when I was 12 years old or older.
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I have been diagnosed with asthma.

SANDIA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 32 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 32 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Asthma Control Questionnaire
Change in Asthma Control Test

SANDIA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: L-citrullineExperimental Treatment1 Intervention
L-citrulline with a dose of 15 g/day will be administered in powder form that is mixed with water and taken orally, continuously and daily for at least 7 weeks. Dispensed at Visits 1 and 1a (if needed). Washout period of at least 5 weeks and then enter crossover phase of an additional 7 weeks. Drug will be dispensed at Visit 4.
Group II: Matching PlaceboPlacebo Group1 Intervention
Administered in powder form that is mixed with water and taken orally, continuously, and daily for at least 7 weeks. Dispensed at Visits 1 and 1a (if needed). Washout period of at least 5 weeks and then enter crossover phase of an additional 7 weeks. Drug will be dispensed at Visit 4.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,466 Total Patients Enrolled
20 Trials studying Asthma
2,925 Patients Enrolled for Asthma
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,816 Total Patients Enrolled
58 Trials studying Asthma
8,247 Patients Enrolled for Asthma
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,838 Previous Clinical Trials
47,851,594 Total Patients Enrolled
276 Trials studying Asthma
112,491 Patients Enrolled for Asthma

Media Library

L-ctirulline Clinical Trial Eligibility Overview. Trial Name: NCT03885245 — Phase 2
Asthma Research Study Groups: Matching Placebo, L-citrulline
Asthma Clinical Trial 2023: L-ctirulline Highlights & Side Effects. Trial Name: NCT03885245 — Phase 2
L-ctirulline 2023 Treatment Timeline for Medical Study. Trial Name: NCT03885245 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential health risks associated with L-citrulline?

"L-citrulline has not been proven effective in any clinical trial, however it did receive a score of 2 due to the lack of evidence suggesting it is unsafe."

Answered by AI

Could older adults potentially benefit from this treatment option?

"This particular clinical trial is only seeking patients that fall between the ages of 18 to 65. There are a total of 345 trials for patients who are underaged and 926 for senior citizens."

Answered by AI

What are the requirements to join this clinical trial?

"This study is seeking 60 individuals with asthma that are between 18-65 years old. The most important thing applicants need to meet the following criteria: adequate completion of informed consent process, confirmation of asthma diagnosis by a physician, the ability to perform reproducible spirometry according to ATS criteria, pre-bronchodilator FEV1 >/= 50% of predicted at Visit 0, all racial/ethnic backgrounds may participate, BMI >/= 30, regular treatment with ICS or ICS/LABA or LAMA combination medication for at least 1 month; participants can be on biologics., smoking history"

Answered by AI

How many volunteers are being taken on for this experiment?

"Yes, as indicated by the clinicaltrials.gov website, this trial is still looking for patients to enroll. The 60 participants will be recruited from a single location and the study's timeline began on October 1st, 2021."

Answered by AI

Are investigators still looking for new participants for this experiment?

"The trial, as indicated by recent updates on clinicaltrials.gov, is still looking for participants. Originally posted on October 1st 2021, the study has made edits as recently as January 6th 2022."

Answered by AI

Is L-citrulline a new medication?

"There are 4 clinical trials studying L-citrulline presently, with none of them in Phase 3. The locations for these trials span from Durham, North carolina to _____ ."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
Duke University (Asthma, Allergy and Airway Center)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Supplementing L-citrulline to Overweight Late Asthma oNset Phenotypes
2021. "Supplementing L-citrulline to Overweight Late Asthma oNset Phenotypes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03885245.
All > Pediatric Asthma > Overweight
~4 spots leftby Jun 2024
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