Role of Magnesium Supplementation in the Treatment of Depression
NCT ID: NCT02466087
Last Updated: 2019-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
126 participants
INTERVENTIONAL
2015-05-31
2016-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Mg Cl
500mg Mg Cl per day for 6 weeks
Mg Cl
Four supplements a day for 6 weeks.
Control
No intervention
No interventions assigned to this group
Interventions
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Mg Cl
Four supplements a day for 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* A Patient Health Questionnaire-9 (PHQ-9) score of greater or equal to 5 but less than 20
* People who are currently being treated for depression are still eligible to participate but their treatment must be stable (no changes in medication dose or brand and/or no changes in therapy regimen for at least 2 months).
Exclusion Criteria
* 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
* Long Term Antibiotics
* Fluoroquinolone
* Trientine or Penicillamine
* Long Term Antivirals
* Digoxin
* Bisphosphonates
* Eltrombopag
* Opiods
* Calcium Channel Blockers
* Deferiprone
* Doxercalciferol
* Unable or unwilling to stop taking a magnesium supplement
18 Years
ALL
No
Sponsors
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University of Vermont
OTHER
Responsible Party
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Emily Tarleton
Bionutrition Research Manager
Principal Investigators
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Emily Tarleton, MS, RD
Role: PRINCIPAL_INVESTIGATOR
University of Vermont
Locations
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University of Vermont
Burlington, Vermont, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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M15-337
Identifier Type: -
Identifier Source: org_study_id
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