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NCT02496676 · ClinicalTrials.gov registry record · Phase 1

Magnesium Supplementation in People With XMEN Syndrome

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
8
Enrollment target

NCT02496676 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 8 participants.

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The verdict

NCT02496676, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
8 participants
Enrollment target

Study 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.

Interventions

  • OTHER Placebo
  • DIETARY_SUPPLEMENT Magnesium L-threonate
  • DRUG Intravenous (IV) magnesium sulfate (MgSO4)

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2016-05-17
Est. Completion 2020-04-23
Phase Phase 1

What the Registry Record Tells You About NCT02496676

The ClinicalTrials.gov registry entry for NCT02496676 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT02496676 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02496676 about?

NCT02496676 is a clinical study titled "Magnesium Supplementation in People With XMEN Syndrome". 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 magnesi...

What is the current status of trial NCT02496676?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2016-05-17. Estimated completion is 2020-04-23.

What interventions are being tested in trial NCT02496676?

The interventions under investigation include: Placebo (OTHER), Magnesium L-threonate (DIETARY_SUPPLEMENT), Intravenous (IV) magnesium sulfate (MgSO4) (DRUG).

Who is sponsoring clinical trial NCT02496676?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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