Role of Magnesium Supplementation in the Treatment of Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire-9
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adults at least 18 years of age
- •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).
排除标准
- •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
- •Gastritis
- •Pregnant as reported by potential volunteer
- •Myasthenia Gravis
- •Planned elective surgery
- •Currently taking
- •Long Term Antibiotics
- •Fluoroquinolone
- •Trientine or Penicillamine
- •Long Term Antivirals
- •Bisphosphonates
- •Eltrombopag
- •Calcium Channel Blockers
- •Deferiprone
- •Doxercalciferol
- •Unable or unwilling to stop taking a magnesium supplement
研究组 & 干预措施
Mg Cl
500mg Mg Cl per day for 6 weeks
干预措施: Mg Cl (Drug)
结局指标
主要结局
Patient Health Questionnaire-9
时间窗: 12 weeks
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.
次要结局
- Generalized Anxiety Disorder 7 Item Questionnaire(12 weeks)
- Change in Headaches While Taking Supplements(12 weeks)
研究者
Emily Tarleton
Bionutrition Research Manager
University of Vermont