NCT02943161

Brief Summary

This study will evaluate whether treatment with L-citrulline, which is an amino acid found in some foods, can increase levels of L-arginine and thereby restore the concentration of nitric oxide (NO) in the airways.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

April 5, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

October 21, 2016

Last Update Submit

February 25, 2020

Conditions

Asthma

Keywords

ObesityL-citrulline

Outcome Measures

Primary Outcomes (1)

  • Change in Exhaled Nitric Oxide (eNO)

    Change in eNO levels before and after treatment with open label L-citrulline at 15g/day

    2 weeks or 14 days

Secondary Outcomes (1)

  • Change in Plasma L-arginine/ADMA Ratio

    2 weeks or 14 days

Other Outcomes (1)

  • Change in Asthma Control Score

    2 weeks or 14 days

Study Arms (1)

L-Citrulline

EXPERIMENTAL

In this pilot study subjects with asthma that have an increased body mass index compatible with being obese, will be invited to participate in a short open-label treatment with 15g/day of L-citrulline for two weeks. Study participants will be asked to do lung function testing and donate blood before and after taking the supplement. L-citrulline is safe and well tolerated and has been used at much higher doses without significant side effects.

Dietary Supplement: L-Citrulline

Interventions

L-CitrullineDIETARY_SUPPLEMENT

The purpose of this study is to see if citrulline supplementation will restore NO levels and lung function in subjects with asthma.

L-Citrulline

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adequate completion of informed consent process with written documentation
  • Male and female patients, 18 - 70 years old, inclusive
  • Physician diagnosis of asthma (for medical records, ICD 10 coding for physician's diagnosis)
  • All racial/ethnic backgrounds may participate
  • BMI ≥ 30
  • Treatment of controller asthma medication(s) ≥ 4 weeks
  • Smoking history ≤10 pack years and no smoking in the last year
  • V1 eNO ≤ 30ppb (may be repeated 3x during visit; lowest ppb will be kept)

You may not qualify if:

  • Respiratory tract infection within the 4 weeks prior to the study (may re-enroll after 4 weeks).
  • Oral or systemic corticosteroid burst (for any indication) within the 4 weeks
  • One-time doses, such as intra-articular injections into a shoulder or knee joint, require a 2-week washout.
  • Asthma-related ER visit within the previous 4 weeks of Visit 1
  • Significant concomitant medical illness, including (but not limited to)
  • Heart disease
  • Cancer
  • Uncontrolled diabetes,
  • Chronic renal failure (creatinine \> 2.0) at Visit 1 (Associated with higher ADMA levels)
  • Untreated sleep apnea
  • Other chronic lung/respiratory diseases (COPD, IPF, etc.)
  • High dose inhaled steroids (\> 1000 mcg/day of Fluticasone or equivalent)
  • Current statin use (statins lower ADMA levels); patients may stop statins with approval from their primary physician and enroll after a 6-week washout
  • Positive urine pregnancy test at Visit 1 or at any time during the study
  • Intolerance or allergy to L-arginine or L-citrulline
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

AsthmaObesity

Interventions

Citrulline

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, DiaminoAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Fernando Holguin, MD, MPH

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2016

First Posted

October 24, 2016

Study Start

April 5, 2017

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

February 27, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

Sharing de-identified data with co-investigators approved by the IRB and Duke University

Locations

US(2)