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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01048905
Other study ID # 1R01FD003531-01
Secondary ID IRB 2008-0591R01
Status Completed
Phase Phase 2
First received
Last updated
Start date March 2009
Est. completion date March 2014

Study information

Verified date June 2021
Source UCSF Benioff Children's Hospital Oakland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary hypothesis of this study is that glutamine supplementation will improve the erythrocyte glutamine/glutamate ratio, a biomarker of oxidative stress, hemolysis and pulmonary hypertension (PH) in sickle cell disease (SCD) and thalassemia (Thal) patients with PH. PH is defined as a tricuspid regurgitant jet velocity (TRV) on Doppler echocardiography > 2.5 m/s. We also predict that glutamine therapy will increase arginine bioavailability and subsequently alter sickle red cell endothelial interaction that can be identified using endo-PAT technology through nitric oxide (NO) generation, leading to changes in biological markers, and clinical outcome. Specifically our second hypothesis is that oral glutamine will decrease biomarkers of hemolysis and adhesion molecules, and improve the imbalanced arginine-to-ornithine ratio that occurs in hemolytic anemias, leading to improved arginine bioavailability and clinical endpoints of endothelial dysfunction and PH in patients with SCD and Thal.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years and older
Eligibility Inclusion Criteria: - Established diagnosis of SCD (Hb SS, SC or SBeta- thalassemia) or Thal - PH documented by echocardiography, defined as at TRV greater than 2.5 m/s - Age greater than or equal to 4 years Exclusion Criteria: - Inability to take or tolerate oral medication - Acute crisis or hospitalization within 1 month of enrollment - Hepatic dysfunction (SGPT greater than 3X normal) - Renal dysfunction (Creatinine greater than 2X normal) - Allergy to glutamine - Pregnancy or breastfeeding - Patients on sildenafil (Viagra), calcium channel blockers, or amino acid/protein supplements (other therapies acceptable if stable more than 3 months)

Study Design


Intervention

Drug:
L-Glutamine
Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children < 15 years of age.

Locations

Country Name City State
United States Children's Hospital & Research Center Oakland Oakland California

Sponsors (2)

Lead Sponsor Collaborator
UCSF Benioff Children's Hospital Oakland Food and Drug Administration (FDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Erythrocyte Glutamine/Glutamate Ratio at 8 Weeks Erythrocyte Glutamine/Glutamate Ratio: a novel biomarker of oxidative stress 8 weeks
Secondary Plasma Glutamine 8 weeks
Secondary Tricuspid Regurgitant Jet Velocity on Doppler Echocardiography Tricuspid Regurgitant Jet Velocity was measured using Doppler Echocardiography in meters per second. 8 week
Secondary 6 Minute Walk Distance The six-minute walk test (6MWT) measures the distance in meters an individual is able to walk over a total of six minutes on a hard, flat surface. 8 weeks
Secondary Liver Function Tests Alanine aminotransferase (ALT) Aspartate aminotransferase (AST) 8 weeks
Secondary Renal Function Tests Creatinine Blood urea nitrogen (BUN) 8 weeks
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