Nutritional supplementation for stress, anxiety and depression among adolescent boys and girls: A cluster randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 750
- 试验地点
- 1
研究概览
简要总结
Adolescent mental health problems such as stress anxiety and depression are increasing globally and are often associated with nutritional deficiencies. Micronutrients such as iron vitamin B12 zinc and vitamin D play an important role in brain function neurotransmitter synthesis and emotional regulation. Deficiencies of these nutrients are common among adolescents in India and may contribute to poor mental health outcomes.
This study aims to evaluate the effectiveness of iron vitamin B12 zinc and vitamin D supplementation on stress anxiety and depression scores among adolescent boys and girls studying in government high schools in Kolar Taluka. This is a cluster randomized controlled trial in which selected high schools will be randomized into different intervention arms including iron supplementation vitamin B12 supplementation zinc supplementation vitamin D supplementation and a health education control group.
Baseline assessment of depression anxiety and stress will be done using validated scales. Serum levels of micronutrients will also be assessed. Supplements will be administered under supervision for nine weeks. Post intervention assessment will be conducted to evaluate changes in psychological scores and micronutrient levels.
The findings of this study may help to determine whether nutritional supplementation can be used as a preventive or supportive strategy to improve adolescent mental health in community settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 10.00 Year(s) 至 19.00 Year(s)（—）
- 性别
- All
入选标准
- •Adolescent boys and girls studying in selected government high schools in Kolar.
- •Participants aged 10 to 10 years with mild to moderate stress, anxiety, or depression scores based on screening scales.
- •Willing to provide assent and whose parents or guardians provide written informed consent.
排除标准
- •Participants with severe psychiatric illness requiring immediate clinical intervention.
- •Those currently receiving psychiatric medication.
- •Adolescents with chronic systemic illness.
- •Known allergy or hypersensitivity to study supplements.
- •Severe anemia requiring therapeutic management.
- •Those unwilling to participate or without parental consent.
研究者
Dr Pradeep TS
Sri Devaraj Urs Medical College