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Magnesium Supplementation in People With XMEN Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02496676
Recruitment Status : Completed
First Posted : July 14, 2015
Results First Posted : January 26, 2022
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition XMEN
Interventions Dietary Supplement: Magnesium L-threonate
Other: Placebo
Drug: Intravenous (IV) magnesium sulfate (MgSO4)
Enrollment 8
Recruitment Details  
Pre-assignment Details 8 participants were consented to protocol. 2 participants did not meet inclusion criteria and one participant declined to participate.
Arm/Group Title Magnesium, Then Placebo Placebo, Then Magnesium
Hide Arm/Group Description In phase 1, participants received oral magnesium L-threonate for 12 weeks then crossover to placebo for 12 weeks, followed by a 2-week washout period. In phase 2, all participants received 3 days of intravenous MgSO4 in 3 daily doses totaling 30 mg/kg/day followed by oral magnesium L-threonate for 24 weeks. In phase 1, participants received oral placebo for 12 weeks then crossover to oral magnesium L-threonate for 12 weeks, followed by a 2-week washout period. In phase 2, all participants received 3 days of intravenous MgSO4 in 3 daily doses totaling 30 mg/kg/day followed by oral magnesium L-threonate for 24 weeks.
Period Title: Phase 1 - Period 1
Started 2 3
Completed 2 2
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Period Title: Phase 1 - Period 2
Started 2 2
Completed 2 2
Not Completed 0 0
Period Title: Washout Period
Started 2 2
Completed 2 2
Not Completed 0 0
Period Title: Phase 2 - IV MgSO4
Started 2 2
Completed 2 1
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Period Title: Phase 2 - Oral Magnesium
Started 2 1
Completed 2 1
Not Completed 0 0
Arm/Group Title Magnesium, Then Placebo Placebo, Then Magnesium Total
Hide Arm/Group Description In phase 1, participants received oral magnesium L-threonate for 12 weeks then crossover to placebo for 12 weeks, followed by a 2-week washout period. In phase 2, all participants received 3 days of intravenous MgSO4 in 3 daily doses totaling 30 mg/kg/day followed by oral magnesium L-threonate for 24 weeks. In phase 1, participants received oral placebo for 12 weeks then crossover to oral magnesium L-threonate for 12 weeks, followed by a 2-week washout period. In phase 2, all participants received 3 days of intravenous MgSO4 in 3 daily doses totaling 30 mg/kg/day followed by oral magnesium L-threonate for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 2 3 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
<=18 years
2
 100.0%
2
  66.7%
4
  80.0%
Between 18 and 65 years
0
   0.0%
1
  33.3%
1
  20.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
2
 100.0%
3
 100.0%
5
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
Hispanic or Latino
0
   0.0%
1
  33.3%
1
  20.0%
Not Hispanic or Latino
2
 100.0%
2
  66.7%
4
  80.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
2
 100.0%
2
  66.7%
4
  80.0%
More than one race
0
   0.0%
1
  33.3%
1
  20.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Participants With a ≥0.5 Log Reduction in the Number of EBV-infected B Cells After Magnesium Supplementation as Compared to Placebo - Phase 1
Hide Description 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.
Time Frame After 12 weeks of each intervention
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Magnesium Placebo
Hide Arm/Group Description:
Participants received oral magnesium L-threonate for 12 weeks
Participants received oral placebo for 12 weeks
Overall Number of Participants Analyzed 1 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells After Magnesium Supplementation as Compared to Placebo - Phase 1
Hide Description 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.
Time Frame After 12 weeks of each intervention
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses included only EBV negative subjects who completed phase 1 of the study, which is the crossover phase.
Arm/Group Title Magnesium Placebo
Hide Arm/Group Description:
Participants received oral magnesium L-threonate for 12 weeks
Participants received oral placebo for 12 weeks
Overall Number of Participants Analyzed 3 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells After Magnesium Supplementation as Compared to Placebo - Phase 1
Hide Description 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.
Time Frame After 12 weeks of each intervention
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Magnesium Placebo
Hide Arm/Group Description:
Participants received oral magnesium L-threonate for 12 weeks
Participants received oral placebo for 12 weeks
Overall Number of Participants Analyzed 1 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Participants With a Decrease in the Absolute Number of EBV Infected B Cells Before and After Magnesium Supplementation - Phase 2
Hide Description 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
Time Frame 24 weeks, during phase 2 of study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all EBV positive participants who completed phase 2 of study
Arm/Group Title Magnesium
Hide Arm/Group Description:
In phase 2, participants received 3 days of intravenous MgSO4 daily at 30 mg/kg/day followed by oral magnesium L-threonate for 24 weeks.
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5.Secondary Outcome
Title Participants With 2-fold or Greater Increase in NKG2D Expression in CD8 T+ Cells Before and After Magnesium Supplementation - Phase 2
Hide Description 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
Time Frame 24 weeks, during phase 2 of study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who completed phase 2 of study
Arm/Group Title Magnesium
Hide Arm/Group Description:
In phase 2, participants received 3 days of intravenous MgSO4 daily at 30 mg/kg/day followed by oral magnesium L-threonate for 24 weeks.
Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
6.Secondary Outcome
Title Participants With Adverse Events by Grade
Hide Description

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)
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all subjects who started each arm of the study
Arm/Group Title Phase 1 - Oral Magnesium Phase 1 - Placebo Phase 2 - IV MgSO4 Phase 2 - Oral Magnesium
Hide Arm/Group Description:
In phase 1, participants received oral magnesium L-threonate for 12 weeks
Participants received oral placebo for 12 weeks
In phase 2, participants received 3 days of intravenous MgSO4 in 3 daily doses totaling 30 mg/kg/day
In phase 2, participants received oral magnesium L-threonate for 24 weeks.
Overall Number of Participants Analyzed 4 5 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
4
 100.0%
4
  80.0%
1
  25.0%
2
  66.7%
Grade 2
1
  25.0%
3
  60.0%
1
  25.0%
3
 100.0%
Grade 3
0
   0.0%
2
  40.0%
1
  25.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Participants With Severe Adverse Events
Hide Description Participants with severe adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, version 4) to evaluate severity.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all subjects who started each arm of the study
Arm/Group Title Phase 1 - Oral Magnesium Phase 1 - Placebo Phase 2 - IV MgSO4 Phase 2 - Oral Magnesium
Hide Arm/Group Description:
In phase 1, participants received oral magnesium L-threonate for 12 weeks
Participants received oral placebo for 12 weeks
In phase 2, participants received 3 days of intravenous MgSO4 in 3 daily doses totaling 30 mg/kg/day
In phase 2, participants received oral magnesium L-threonate for 24 weeks
Overall Number of Participants Analyzed 4 5 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase 1 - Oral Magnesium Phase 1 - Placebo Phase 2 - IV MgSO4 Phase 2 - Oral Magnesium
Hide Arm/Group Description In phase 1, participants received oral magnesium L-threonate for 12 weeks Participants received oral placebo for 12 weeks In phase 2, participants received 3 days of intravenous MgSO4 in 3 daily doses totaling 30 mg/kg/day In phase 2, participants received oral magnesium L-threonate for 24 weeks
All-Cause Mortality
Phase 1 - Oral Magnesium Phase 1 - Placebo Phase 2 - IV MgSO4 Phase 2 - Oral Magnesium
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/5 (0.00%)      0/4 (0.00%)      0/3 (0.00%)    
Hide Serious Adverse Events
Phase 1 - Oral Magnesium Phase 1 - Placebo Phase 2 - IV MgSO4 Phase 2 - Oral Magnesium
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/5 (0.00%)      0/4 (0.00%)      0/3 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase 1 - Oral Magnesium Phase 1 - Placebo Phase 2 - IV MgSO4 Phase 2 - Oral Magnesium
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      5/5 (100.00%)      1/4 (25.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders         
Increased tendency to bruise   1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
Lymphadenitis   0/4 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Cardiac disorders         
Dizziness   0/4 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0
Ear and labyrinth disorders         
Otitis media   1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain   3/4 (75.00%)  4 3/5 (60.00%)  8 0/4 (0.00%)  0 0/3 (0.00%)  0
Diarrhoea   1/4 (25.00%)  1 3/5 (60.00%)  3 0/4 (0.00%)  0 1/3 (33.33%)  5
Dyspepsia   1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
Hiccups   1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
Mouth ulceration   0/4 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Nausea   1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
Vomiting   0/4 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0
Gastrooesophageal reflux disease   1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
General disorders         
Fatigue   1/4 (25.00%)  2 0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
Pain   1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
Infections and infestations         
Acute sinusitis   0/4 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Skin infection   0/4 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Investigations         
Alanine aminotransferase increased   1/4 (25.00%)  1 0/5 (0.00%)  0 1/4 (25.00%)  2 2/3 (66.67%)  2
Aspartate aminotransferase increased   0/4 (0.00%)  0 0/5 (0.00%)  0 1/4 (25.00%)  1 1/3 (33.33%)  2
Neutrophil count decreased   0/4 (0.00%)  0 0/5 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
White blood cell count increased   1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Myalgia   1/4 (25.00%)  1 0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
Nervous system disorders         
Headache   2/4 (50.00%)  13 3/5 (60.00%)  14 0/4 (0.00%)  0 1/3 (33.33%)  2
Psychiatric disorders         
Sleep disorder   0/4 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough   2/4 (50.00%)  2 0/5 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0
Epistaxis   0/4 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0
Nasal congestion   0/4 (0.00%)  0 1/5 (20.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ravell Aumaitre, Juan
Organization: National Institute of Allergy and Infectious Diseases
Phone: +1 301 761 6669
EMail: juan.ravell@nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT02496676    
Other Study ID Numbers: 150161
15-I-0161 ( Other Identifier: National Institutes of Health )
First Submitted: July 9, 2015
First Posted: July 14, 2015
Results First Submitted: October 27, 2021
Results First Posted: January 26, 2022
Last Update Posted: March 2, 2022