Glutamine Supplementation in People With Immune Dysregulation
Status:
Withdrawn
Trial end date:
2021-01-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Early Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)