Effect of Vitamin D Supplementation on Mental Health: An Exploratory Study on A University Students Suffering From Vitamin D Deficiency
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Evaluation of the correlation between vitamin D deficiency and presence and severity of anxiety, stress and depressive symptoms.
研究概览
简要总结
University students are susceptible to psychological burdens such as depressive symptoms, anxiety, and stress which might have been linked to vitamin D deficiency. Low serum vitamin D level is well recognized around the world. Vitamin D has been reported to modulate several neurological pathways in the brain that control psychological function. As a result, the purpose of this study is to evaluate the effect of vitamin D supplementation on the presence of depressive symptoms, anxiety, and stress in university students. The study will include two phases. The first phase is a cross-sectional phase assessing the prevalence vitamin D deficiency in addition to psychological symptoms. The second phase is a randomized controlled clinical trial that aims to assess the effect of vitamin D supplementation on the prevalent psychological symptoms and its impact on the academic performance among university students. The study will look at the relationship between mental health and vitamin D deficiency, as well as how it will affect academic performance of university students.
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
- None
入排标准
- 年龄范围
- 18 Years 至 22 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For phase 1: sample will be selected using convenient sampling method where all students with an age range 18-22 years old fulfilling the eligibility criteria will be educated about the study protocol and will be asked to participate in the study.
- •For phase 2: students who diagnosed with deficient vitamin D level will be asked to participate in the study.
排除标准
- •Hypersensitivity to oral vitamin D supplements such as Diviton or Vidrop.
- •Students taking medications affecting vitamin D metabolism such as anti-seizure medications: phenytoin, phenobarbital and carbamazepine, isotretinoin, steroids: dexamethasone, antibiotics: isoniazid and rifampin and antifungals: clotrimazole.
- •Students taking antidepressants, drug for bipolar disorder treatment like lithium and antipsychotic agents like olanzapine.
- •Students with insufficient vitamin D level (20-30 ng/mL).
- •Students with confirmed diagnosis with psychiatric illness.
- •Students with a history of liver disease or dysfunction.
- •Students with a history of kidney disease or dysfunction.
研究组 & 干预措施
Control group
This group does not take any drug. It will take placebo.
干预措施: Placebo (Other)
Intervention group
This group will take Vitamin D
干预措施: Vit D (Drug)
结局指标
主要结局
Evaluation of the correlation between vitamin D deficiency and presence and severity of anxiety, stress and depressive symptoms.
时间窗: 3 months
Evaluation of the correlation between vitamin D deficiency and presence and severity of anxiety, stress and depressive symptoms.
次要结局
未报告次要终点
研究者
Nouran Hussien Kandeel
Nouran hussien kandeel
German University in Cairo