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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants with a ≥ 0.5 log decrease in the absolute number of Epstein-Barr virus (EBV) infected B-cells by flow cytometric Fluorescence in situ hybridization (FISH) assay after 12 weeks of oral magnesium supplementation compared to 12 weeks of placebo.
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Magnesium L-threonate
- DRUG Intravenous (IV) magnesium sulfate (MgSO4)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2016-05-17 |
| Est. Completion | 2020-04-23 |
| Phase | Phase 1 |
What the finished NCT02496676 record still lists
NCT02496676 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02496676 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02496676's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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