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Magnesium Supplementation in People With XMEN Syndrome

NCT02496676 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-03-02

Study results available
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Summary

Background:

\- X-linked immunodeficiency with magnesium defect, Epstein-Barr virus infection, and neoplasia syndrome is called XMEN syndrome. In this genetic condition, the cells have less magnesium than normal. This makes it hard for the body to fight infections. Researchers want to see if magnesium supplements can make it easier for the body to fight infection.

Objective:

\- To see if magnesium supplements can strengthen the immune system and reduce the amount of Epstein-Barr virus in people with XMEN syndrome.

Eligibility:

\- People ages 6 and older who have XMEN syndrome

Design:

* Participants will be screened with:
* Medical history
* Physical exam
* CT scan: Participants will drink a contrast and may get dye through an IV in the arm. They will lie in a machine that takes pictures of the body.
* EKG: Small sticky patches on the body will trace heart rhythm.
* Blood tests
* The study has 2 parts.
* Participants doing both parts will participate for 1 year and visit the clinic about 15 times. These visits will include a physical exam and blood and urine tests.
* Participants doing only the first part finish in 6 months and have fewer visits.
* For study part 1, participants will take magnesium pills for 3 months and placebo pills for another 3 months.
* At 3 and 6 months, they will have physical exam, medical history, blood and urine tests, and an EKG.
* If the magnesium pills are not helpful, participants will do study part 2.
* They will be admitted to the hospital for 4 5 days to get magnesium for 3 days through an arm vein.
* They will take magnesium pills for another 6 months.

Conditions

  • XMEN

Interventions

DIETARY_SUPPLEMENT

Magnesium L-threonate

In Part I, participants will receive 12 weeks of oral magnesium L-threonate; will be dose escalated based on weight. In Part 2, participants will receive 24 weeks of oral magnesium L-threonate; will be dose escalated based on weight.

OTHER

Placebo

In Part I, participants will receive 12 weeks of oral placebo; will be dose escalated based on weight.

DRUG

Intravenous (IV) magnesium sulfate (MgSO4)

In Part II, participants will be hospitalized to receive 3 days of IV magnesium sulfate (MgS04).

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Juan C Ravell Aumaitre, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-17
Primary Completion
2020-04-23
Completion
2020-04-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02496676 on ClinicalTrials.gov