Trial · NCT02496676
Magnesium Supplementation in People With XMEN Syndrome
NCT02496676, Phase 1, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2022-01-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Magnesium Supplementation in People With XMEN Syndrome. Trials, record NCT02496676. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02496676
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Magnesium Supplementation in People With XMEN Syndrome
- NCT number
- NCT02496676
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- XMEN
- Interventions
- Magnesium L-threonate, Placebo, Intravenous (IV) magnesium sulfate (MgSO4)
- First posted
- 2015-07-14
- Last updated
- 2022-03-02
- Results first posted
- 2022-01-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | After 12 weeks of each intervention | 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. |
| Primary | Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells After Magnesium Supplementation as Compared to Placebo - Phase 1 | After 12 weeks of each intervention | Participants with difference of a 2-fold or greater increase in NKG2D expression in cluster of differentiation 8 (CD8+) T cells after 12 weeks of oral magnesium supplementation versus 12 weeks of placebo. |
| Secondary | Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells After Magnesium Supplementation as Compared to Placebo - Phase 1 | After 12 weeks of each intervention | Participants with difference of a 2-fold or greater increase in NKG2D expression in cluster of differentiation 8 (CD8+) T cells after 12 weeks of oral magnesium supplementation versus 12 weeks of placebo. |
| Secondary | Participants With a Decrease in the Absolute Number of EBV Infected B Cells Before and After Magnesium Supplementation - Phase 2 | 24 weeks, during phase 2 of study | 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 before and after 24 weeks of magnesium supplementation |
| Secondary | Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells Before and After Magnesium Supplementation - Phase 2 | 24 weeks, during phase 2 of study | Participants with a 2-fold or greater increase in NKG2D expression in CD8+ T cells before and after magnesium supplementation for 24 weeks in phase 2 of study |
| Secondary | Participants With Adverse Events by Grade | 1 year | Participants with adverse events by grade using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, version 4) grading criteria. * Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention indicated * Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) * Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL * Grade 4 Life-threatening consequences; urgent intervention indicated * Grade 5 Death related to adverse event (AE) |
| Secondary | Participants With Severe Adverse Events | 1 year | Participants with severe adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, version 4) to evaluate severity. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | After 12 weeks of each intervention | The analyses included only EBV positive subject who completed Phase 1 of the study. In this phase, two participants were EBV positive, but only one participant completed Phase 1. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells After Magnesium Supplementation as Compared to Placebo - Phase 1 | After 12 weeks of each intervention | The analyses included only EBV negative subjects who completed phase 1 of the study, which is the crossover phase. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells After Magnesium Supplementation as Compared to Placebo - Phase 1 | After 12 weeks of each intervention | The analyses included only EBV positive subject who completed Phase 1 of the study. In this phase, two participants were EBV positive, but only one participant completed Phase 1. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With a Decrease in the Absolute Number of EBV Infected B Cells Before and After Magnesium Supplementation - Phase 2 | 24 weeks, during phase 2 of study | Analysis included all EBV positive participants who completed phase 2 of study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells Before and After Magnesium Supplementation - Phase 2 | 24 weeks, during phase 2 of study | Analysis included all participants who completed phase 2 of study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With Adverse Events by Grade | 1 year | Analysis included all subjects who started each arm of the study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With Severe Adverse Events | 1 year | Analysis included all subjects who started each arm of the study | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With a ≥0.5 Log Reduction in the Number of EBV-infected B Cells After Magnesium Supplementation as Compared to Placebo - Phase 1 | Magnesium | 0 | Participants | ||
| Participants With a ≥0.5 Log Reduction in the Number of EBV-infected B Cells After Magnesium Supplementation as Compared to Placebo - Phase 1 | Placebo | 0 | Participants | ||
| Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells After Magnesium Supplementation as Compared to Placebo - Phase 1 | Magnesium | 0 | Participants | ||
| Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells After Magnesium Supplementation as Compared to Placebo - Phase 1 | Placebo | 0 | Participants | ||
| Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells After Magnesium Supplementation as Compared to Placebo - Phase 1 | Magnesium | 0 | Participants | ||
| Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells After Magnesium Supplementation as Compared to Placebo - Phase 1 | Placebo | 0 | Participants | ||
| Participants With a Decrease in the Absolute Number of EBV Infected B Cells Before and After Magnesium Supplementation - Phase 2 | Magnesium | 0 | Participants | ||
| Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells Before and After Magnesium Supplementation - Phase 2 | Magnesium | 0 | Participants | ||
| Participants With Adverse Events by Grade | Phase 1 - Oral Magnesium | Grade 1 | 4 | Participants | |
| Participants With Adverse Events by Grade | Phase 1 - Placebo | Grade 1 | 4 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 - Period 1 | STARTED | Magnesium, Then Placebo | 2 | |
| Phase 1 - Period 1 | STARTED | Placebo, Then Magnesium | 3 | |
| Phase 1 - Period 1 | COMPLETED | Magnesium, Then Placebo | 2 | |
| Phase 1 - Period 1 | COMPLETED | Placebo, Then Magnesium | 2 | |
| Phase 1 - Period 1 | NOT COMPLETED | Magnesium, Then Placebo | 0 | |
| Phase 1 - Period 1 | NOT COMPLETED | Placebo, Then Magnesium | 1 | |
| Phase 1 - Period 2 | STARTED | Magnesium, Then Placebo | 2 | |
| Phase 1 - Period 2 | STARTED | Placebo, Then Magnesium | 2 | |
| Phase 1 - Period 2 | COMPLETED | Magnesium, Then Placebo | 2 | |
| Phase 1 - Period 2 | COMPLETED | Placebo, Then Magnesium | 2 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events104
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Phase 1 - Oral Magnesium | 1 | 4 | 1 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Phase 1 - Placebo | 0 | 5 | 0 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Phase 2 - IV MgSO4 | 0 | 4 | 0 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Phase 2 - Oral Magnesium | 0 | 3 | 0 |
| other | Lymphadenitis | Blood and lymphatic system disorders | Phase 1 - Oral Magnesium | 0 | 4 | 0 |
| other | Lymphadenitis | Blood and lymphatic system disorders | Phase 1 - Placebo | 0 | 5 | 0 |
| other | Lymphadenitis | Blood and lymphatic system disorders | Phase 2 - IV MgSO4 | 0 | 4 | 0 |
| other | Lymphadenitis | Blood and lymphatic system disorders | Phase 2 - Oral Magnesium | 1 | 3 | 1 |
| other | Dizziness | Cardiac disorders | Phase 1 - Oral Magnesium | 0 | 4 | 0 |
| other | Dizziness | Cardiac disorders | Phase 1 - Placebo | 1 | 5 | 1 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1 - Oral Magnesium | 0 | 4 |
| Total, all-cause mortality | Phase 1 - Placebo | 0 | 5 |
| Total, all-cause mortality | Phase 2 - IV MgSO4 | 0 | 4 |
| Total, all-cause mortality | Phase 2 - Oral Magnesium | 0 | 3 |
| Total, other adverse events | Phase 1 - Oral Magnesium | 4 | 4 |
| Total, other adverse events | Phase 1 - Placebo | 5 | 5 |
| Total, other adverse events | Phase 2 - IV MgSO4 | 1 | 4 |
| Total, other adverse events | Phase 2 - Oral Magnesium | 3 | 3 |
| Total, serious adverse events | Phase 1 - Oral Magnesium | 0 | 4 |
| Total, serious adverse events | Phase 1 - Placebo | 0 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Magnesium vs Placebo: Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells After Magnesium Supplementation as Compared to Placebo - Phase 1 | Trial comparisons |
| Magnesium vs Placebo: Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells After Magnesium Supplementation as Compared to Placebo - Phase 1 | Trial comparisons |
| Magnesium vs Placebo: Participants With a ≥0.5 Log Reduction in the Number of EBV-infected B Cells After Magnesium Supplementation as Compared to Placebo - Phase 1 | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02496676
GET https://conductscience.org/api/trials/v1/NCT02496676/results?page=2