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Glutamine Supplementation in People With Immune Dysregulation

NCT04019769 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2020-03-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

L-glutamine

product will be obtained by Endari and administered by NIH pharmacy. Patient will take supplement as prescribed

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Joshua D Milner, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-12
Primary Completion
2021-01-01
Completion
2021-01-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04019769 on ClinicalTrials.gov