At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 11 enrolled

Drug / intervention

First Intervention (14 days) +2 moredietary

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02838979

NCT02838979Phase 2Completed

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Randomized Cross-over Trial of Oral L-Glutamine vs Maltodextrin on Mitochondrial Function in Chronic Kidney Disease

University of Washington·interventional·Posted Jul 20, 2016·Updated Jul 14, 2022

In Brief

A Phase 2 clinical trial evaluating First Intervention (14 days), Washout (3 weeks), and 1 other intervention for Cardiovascular Disease and 4 related conditions. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The primary goal of proposed investigation is to study the impact of oral glutamine supplementation on muscle mitochondrial and endothelial cell function measured mitochondrial energetics and vascular function using 31P magnetic resonance spectroscopy and optical spectroscopy (MRS/OS) among persons with moderate-severe CKD. The secondary objective is to describe the impact of oral glutamine supplementation on mitochondrial metabolic profile as well as inflammatory and oxidative stress biomarkers among persons with chronic kidney disease.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCardiovascular Disease, Sarcopenia, Endothelial Dysfunction, Muscle Mitochondrial Function, Kidney Disease

CountriesUnited States

CollaboratorsNew York Medical College, Emory University, Vanderbilt University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 2CompletedFinished

20162017201820192020202120222023202420252026

Enrollment StartFeb 2016

First PostedJul 2016

Primary CompletionOct 2017

Study CompletionJan 2018

TodayJul 2026

First PostedJul 20, 2016

Enrollment StartFeb 25, 2016

Primary CompletionOct 1, 2017

Study CompletionJan 31, 2018

TodayJul 2, 2026

Enrollment to primary: 1.6 yearsPosted 10.0 years ago

Interventions

First Intervention (14 days)dietary

Oral Glutamine or Maltodextrin for 2 weeks

Washout (3 weeks)other

No study product is taken prior to beginning crossover

Second Intervention (14 days)dietary

Oral Glutamine or Maltodextrin for 2 weeks