Phase 2
N=5
Magnesium Supplementation in People With XMEN Syndrome
XMEN
Bottom Line
View on ClinicalTrials.gov: NCT02496676 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Participants With a ≥0.5 Log Reduction in the Number of EBV-infected B Cells After Magnesium Supplementation as Compared to Placebo - Phase 1 — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Magnesium L-threonate (Dietary_supplement); Placebo (Other); Intravenous (IV) magnesium sulfate (MgSO4) (Drug)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- Male
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With a ≥0.5 Log Reduction in the Number of EBV-infected B Cells After Magnesium Supplementation as Compared to Placebo - Phase 1 |
0; 0 | — |
| PRIMARY Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells After Magnesium Supplementation as Compared to Placebo - Phase 1 |
0; 0 | — |
| SECONDARY Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells After Magnesium Supplementation as Compared to Placebo - Phase 1 |
0; 0 | — |
| SECONDARY Participants With a Decrease in the Absolute Number of EBV Infected B Cells Before and After Magnesium Supplementation - Phase 2 |
— | — |
| SECONDARY Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells Before and After Magnesium Supplementation - Phase 2 |
— | — |
| SECONDARY Participants With Adverse Events by Grade |
4; 4; 1; 2; 1; 3 | — |
| SECONDARY Participants With Severe Adverse Events |
0; 0; 0; 0 | — |
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.
Eligibility Criteria
- INCLUSION CRITERIA:
All of the following inclusion criteria must be met prior to enrollment:
- Molecular diagnosis of the MAGT1 genetic defect
- Greater than or equal to 6 years years of age
- Willingness to stop magnesium supplements (other than the study agent) and any multivitamins or over-the counter-supplements that may contain magnesium for the duration of the study
- Willingness to go without magnesium supplementation during a 12-week placebo period and during both 2-week washout periods (pre-study and mid-study)
- Willingness to have samples stored for future research
- Must have a physician at home for follow-up care
EXCLUSION CRITERIA
- Chemotherapy or radiotherapy for lymphoma within 12 months prior to enrollment
- Rituximab exposure within 6 months prior to enrollment
- Systemic symptoms suggestive of evolving lymphoma
- History of clinically significant cardiac arrhythmias or cardiac defects
- Renal insufficiency (calculated creatinine clearance 2 mmol/L (>5 mg/dL)
- Human immunodeficiency virus (HIV) seropositivity
- Signs or symptoms of life-threatening active microbial infection
- History of hypersensitivity to any of the study agents
- Any condition that, in the investigator s opinion, may substantially increase the risk associated with study participation or compromise the study s scientific objectives
- Participation in a clinical protocol which includes an intervention that, in the opinion of the investigator, may affect the results of the current study
Data sourced from ClinicalTrials.gov (NCT02496676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.