Randomized Double-Blind Placebo-Controlled Pilot Study of Vitamin D Supplementation for the Treatment of Bipolar Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in Montgomery-Åsberg Depression Rating Scale
研究概览
简要总结
The purpose of this study is to whether vitamin d supplementation in those with low levels may reduce depression symptoms in people experiencing bipolar depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults >18years old
- •Bipolar disorder (I,II or NOS),
- •MADRS Score>7 (mild),
- •25(OH)D level <30ng/ml (insufficient).
- •able to take the prescribed vitamin D by mouth
排除标准
- •Systemic diseases such as:
- •liver and kidney diseases,
- •known parathyroid disorder,
- •disorders of vitamin D metabolism,
- •taking vitamin D replacement therapy,
- •fat digestion disorder,
- •diabetes mellitus,
- •gi surgery
- •If the serum calcium in the range 2.50-2.55 mmol L, inclusion required a serum PTH below 5.0 pmol L-acute psychiatric urgency:
- •active suicidality,
- •acute psychosis,
- •active substance use<6mo or
- •pregnant or nursing females
研究组 & 干预措施
Vitamin D3
Vitamin D3, Cholecalciferol, 5000IU po qday for 12 weeks
干预措施: Vitamin D3, Cholecalciferol (Drug)
Placebo
methylcellulose po qday for 12weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Montgomery-Åsberg Depression Rating Scale
时间窗: baseline and at 12 week completion
Montgomery-Åsberg Depression Rating Scale Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts Usual cutoff points are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression.
次要结局
未报告次要终点
研究者
Wendy Marsh
Assistant Professor
University of Massachusetts, Worcester