Glutamine Supplementation in People With Immune Dysregulation
Withdrawn before enrolling · Early Phase 1
Conditions studied: Eczema, MTOROC1 Signaling
In brief
Background: Glutamine is an amino acid. People get amino acids from food or from the body s cells. The body needs amino acids to stay healthy. Glutamine might help treat some people with immune system problems like atopic dermatitis. Objective: To study the safety and effectiveness of glutamine supplements for people with certain immune system problems. Eligibility: People ages 5-65 with atopic dermatitis and other immune system problems Design: Participants will be screened in another protocol. Participants will have 8 visits. Visit 1 includes: Physical exam Medical history Blood and urine tests Saliva sample Nutrition assessment For participants with AD, photographs of the skin Participants will get a diary to record their symptoms every day during the study. They will record any glutamine side effects and bring the diary to every visit. Visit 2 is about 1 month after visit 1. Participants will repeat visit 1 tests and get glutamine to take home. It is a powder that can be added to drinks or food. They will take it twice a day for 3 months. They will record their doses in a diary each day and bring the diary to all visits. Participants will have a phone call 5 days after starting glutamine to discuss how they are feeling. Visit 3 is about 7 days after participants start taking glutamine. They will have blood tests. Visits 4, 5, and 6 occur each month participants are taking glutamine. Participants will repeat visit 1 tests. Participants will stop taking glutamine after visit 6. Visits 7 and 8 occur 1 and 3 months after participants stop taking glutamine. Participants will repeat visit 1 tests.
Key facts
- Study ID
- NCT04019769
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 0
- Starts
- 2020-03-12
- Expected to finish
- 2021-01-01
- Last updated by the study team
- 2020-03-16
Who can join
Age: 5 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Individuals meeting any of the following criteria will be excluded from study participation:
- Current, active infection requiring treatment.
- Current treatment with a chemotherapeutic agent.
- Participation in an ongoing research protocol evaluating an investigational agent.
- Treatment with approved prescription medications may be exclusionary, to be determined on a case-by-case basis by the principal investigator.
- Significant liver or kidney disease (serum glutamic oxaloacetic transaminase [SGOT], serum glutamine pyruvic transaminase [SGPT], or alkaline phosphatase >2.5 (SqrRoot) upper limit of normal [ULN], total bilirubin >1.5 (SqrRoot) ULN, or serum creatinine >1.5 (SqrRoot) ULN) in the past 30 days.
- Persons with an active seizure disorder. For persons with a prior history of seizures, the person should be seizure free for 5 years and not on any anti-seizure medication in order to be enrolled into the study. (Since glutamine is metabolized to glutamate and ammonia, and glutamate is the main excitatory neurotransmitter in the central nervous system, there is a theoretical increased risk of seizures.)
- Allergy to monosodium glutamate.
- Malabsorption.
- Pregnancy.
- Breastfeeding.
- Any condition that, in the opinion of the investigator, contraindicates participation in this study.
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.