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The objective of this project is to test the hypothesis that magnesium supplementation will decrease depressive symptoms in adults.
This study takes place over 12 consecutive weeks. While the investigators will follow the volunteers for the full 12 weeks volunteers will only take magnesium supplements for 6 consecutive weeks. Volunteers will be randomly assigned to start the supplement at week 1 or week 7. Volunteers will take two supplement two times a day for a total of 248 mg elemental magnesium daily in the form of magnesium chloride. This amount of magnesium is less than the tolerable upper limit of 350 mg per day. The supplements will be provided. Volunteers will be asked to maintain their normal diet for the 12 weeks of the study.
The primary outcome measure is the PHQ-9 questionnaire, a validated measure of depression. Secondary measures include the GAD-7 for Anxiety and side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mg Cl | Experimental | 500mg Mg Cl per day for 6 weeks |
|
| Control | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mg Cl | Drug | Four supplements a day for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 | Change in score from week 1 to week 6 and week 7 to week 12 (difference in differences) The Patient Health Questionnaire-9 Item is a validated questionnaire with high sensitivity and specificity for the diagnosis of depression. The PHQ-9 score can range from 0 to 27, with the following severity scores: 0-4 None; 5-9 Mild; 10-14 Moderate; 15-19 Moderate to Severe; 20-27 Severe. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Generalized Anxiety Disorder 7 Item Questionnaire | Change in score from week 1 to week 6 and week 7 to 12 (difference in differences) GAD-7 score has been shown to be a valid indication of anxiety symptoms. The GAD-7 score can range from 0 to 21, with the following severity scores: 0-4 None; 5-9 Mild; 10-14 Moderate; 15-21 Severe. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Active delirium or dementia
Medicinal treatment for bipolar disorder, personality disorder or schizophrenia,
Glomerular Filtration Rate of less than 60
Irritable Bowel Disease
Inflammatory Bowel Disease
GERD
Gastritis
Pregnant as reported by potential volunteer
Myasthenia Gravis
Planned elective surgery
Currently taking
Unable or unwilling to stop taking a magnesium supplement
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| Name | Affiliation | Role |
|---|---|---|
| Emily Tarleton, MS, RD | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont | Burlington | Vermont | 05401 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mg Cl (Weeks 1-6), Then no Intervention (Weeks 7-12) | MgCl for weeks 1-6 and then no treatment for weeks 7-12 |
| FG001 | No Intervention (Weeks 1-6), Then MgCl (Weeks 7-12) | No Treatment for weeks 1-6 and then MgCl for weeks 7-12 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention: Weeks 1-6 |
| |||||||||||||
| Second Intervention: Weeks 7-12 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive MgCl first and no intervention first |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Numbers represent participants with analyzable data. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Health Questionnaire-9 | Change in score from week 1 to week 6 and week 7 to week 12 (difference in differences) The Patient Health Questionnaire-9 Item is a validated questionnaire with high sensitivity and specificity for the diagnosis of depression. The PHQ-9 score can range from 0 to 27, with the following severity scores: 0-4 None; 5-9 Mild; 10-14 Moderate; 15-19 Moderate to Severe; 20-27 Severe. | Number of participants with analyzable data. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mg Supplementation | 6 weeks of Mg Supplements | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Tarleton, MS, RD | University of Vermont | 802-847-4730 | emily.tarleton@uvm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 21, 2015 | Jul 28, 2017 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 11, 2016 | Aug 25, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Change in Headaches While Taking Supplements | Change in headaches compared to normal during the 6 weeks on supplements. Change was calculated from 2 time points-start of supplements and end of supplements. Change was recorded as 0, None (same)
| 12 weeks |
| NOT COMPLETED |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Numbers reflect participants with analyzable data | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Secondary | Generalized Anxiety Disorder 7 Item Questionnaire | Change in score from week 1 to week 6 and week 7 to 12 (difference in differences) GAD-7 score has been shown to be a valid indication of anxiety symptoms. The GAD-7 score can range from 0 to 21, with the following severity scores: 0-4 None; 5-9 Mild; 10-14 Moderate; 15-21 Severe. | Posted | Mean | 95% Confidence Interval | scores on a scale | 12 weeks |
|
|
|
| Secondary | Change in Headaches While Taking Supplements | Change in headaches compared to normal during the 6 weeks on supplements. Change was calculated from 2 time points-start of supplements and end of supplements. Change was recorded as 0, None (same)
| headaches | Posted | Mean | 95% Confidence Interval | score on a scale | 12 weeks |
|
|
|
| 62 |
| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | Control | 6 weeks of no MgCl supplements | 0 | 64 | 0 | 64 | 0 | 64 |
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