Effect of Vitamin D Supplementation on Depressive Symptoms in Chinese Early Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 406
- 试验地点
- 2
- 主要终点
- Change in depressive symptom scores
研究概览
简要总结
The goal of this randomized controlled clinical trial is to investigate the effects of vitamin D3 supplementation on depression in Chinese early adolescents with elevated depressive symptoms and vitamin D deficiency. The main question it aims to answer whether vitamin D3 supplementation can reduce depressive symptoms.
Participants in the intervention group will receive vitamin D3 capsules and mental health education. The control group will receive vitamin D3 placebo and mental health education.
Researchers will compare the change in depressive symptoms from baseline to post-intervention at 12 weeks between the intervention and control groups.
详细描述
Investigators will conduct a randomized controlled trial to examine whether vitamin D3 supplementation can improve depressive symptoms. Participants will be recruited from two middle schools. Participants will be randomly assigned into a supplementation or placebo group. Supplementation arm will receive oral dose 2000 IU vitamin D3 per day for 6 weeks and followed by 800 IU per day for 6 weeks; placebo arm will receive placebo every day for 12 weeks. Both of these two groups will receive additional mental health education. For the first 6 weeks, vitamin D or placebo will be administrated every two weeks. For the next 6 weeks, vitamin D or placebo will be administrated every three weeks. The primary outcome of this study is to compare the change of depressive symptoms between supplementation or placebo group from pre- to post-intervention at 12 weeks.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •7th-9th students whose caregivers signed informed consents;
- •students with serum 25(OH)D concentrations below 20 ng/mL;
- •students with self-reported depressive symptoms (BDI-II score of 14 or higher)
排除标准
- •students who are currently receiving or have used anti-psychotic treatments or interventions (including drugs and non-drugs) in the past 3 months;
- •students who have serious health conditions (e.g., organic or functional brain diseases, major psychiatric disorders, cardiovascular diseases, serious infectious diseases, chronic gastrointestinal diseases, and hepatic or renal diseases);
- •students who are currently taking or have taken vitamin D supplements in the past 3 months;
- •students with self-reported serious suicidal ideation, suicidal plans and attempts in the past 3 months;
- •students with intellectual disability;
- •students who are allergic to vitamin D or soybean oil components.
研究组 & 干预措施
Vitamin D3 + Mental Health Education
Vitamin D3: 2000 IU per day for 6 weeks (two capsules of 800 IU plus one capsule of 400 IU), followed by 800 IU (one capsule of 800 IU) per day for 6 weeks.
Mental Health Education: consists of providing a brochure and videos containing information about mental health problems.
干预措施: Mental health education (Behavioral)
Vitamin D3 placebo + Mental Health Education
Vitamin D3 placebo (i.e., soybean oil). Mental Health Education: consists of providing a brochure and videos containing information about mental health problems.
干预措施: Vitamin D3 placebo (Dietary Supplement)
Vitamin D3 placebo + Mental Health Education
Vitamin D3 placebo (i.e., soybean oil). Mental Health Education: consists of providing a brochure and videos containing information about mental health problems.
干预措施: Mental health education (Behavioral)
Vitamin D3 + Mental Health Education
Vitamin D3: 2000 IU per day for 6 weeks (two capsules of 800 IU plus one capsule of 400 IU), followed by 800 IU (one capsule of 800 IU) per day for 6 weeks.
Mental Health Education: consists of providing a brochure and videos containing information about mental health problems.
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
Change in depressive symptom scores
时间窗: From randomization to the end of intervention at 3 months
Depressive symptoms are evaluated by the Chinese version of Beck Depression Inventory (BDI-II-C). The measured outcome was the total BDI-II-C scores. Each of the 21 items can be scored as 0, 1, 2, or 3 points. The range for the BDI-II-C score is 0-63 points; higher scores indicate worse depressive symptoms. Change in BDI-II-C scores from pre to post-intervention were compared between randomized groups, which was the primary outcome of this study.
次要结局
- Sleep Quality Scores(Baseline, 6, 12, 24 and 36 weeks)
- Number of Participants with a Suicidal Ideation Event(From randomization to the occurrence of the endpoint or to the end of evaluation at 12, 24 or 36 weeks.)
- Loneliness Scores(Baseline, 6, 12, 24, 36 weeks)
- Loneliness Scores(Baseline, 6, 12, 24, 36 weeks)
- Patient Health Questionnaire-9 Scores(Baseline, 6, 9, 12, 24 and 36 weeks)
- Anxiety Symptoms Scores(Baseline, 6, 9, 12, 24 and 36 weeks)
- Depressive Symptoms Scores(Baseline, 6, 9, 24 and 36 weeks)
- Sleep Quality Scores(Baseline, 6, 12, 24 and 36 weeks)
- Hopelessness Scores(Baseline, 6, 12, 24 and 36 weeks)
- Number of Participants with a Suicidal Ideation Event(From randomization to the occurrence of the endpoint or to the end of evaluation at 12, 24 or 36 weeks.)
- Psychological Resilience Scores(Baseline, 6, 12 weeks)
- Emotional and Behavioral Problems Scores(Baseline, 6, 9, 12, 24, 36 weeks)
- Emotional Regulation Ability Scores(Baseline, 6, 12 weeks)
研究者
Yuan Mengyuan
Principal Investigator
Anhui Medical University