Psychiatric Disorder
Conditions
Brief summary
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.
Interventions
DRUGVit D
Vitamin D is a fat soluble vitamin used for the treatment of many diseases.
OTHERPlacebo
Placebo is a non drug formulation
Sponsors
Prof. Mohamed Hassan Solayman, Clinical pharmacy Department, German University in Cairo
Prof. May Ahmed Shawki, Clinical Pharmacy Department, Ain Shams University, Egypt
German University in Cairo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 22 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the correlation between vitamin D deficiency and presence and severity of anxiety, stress and depressive symptoms. | 3 months | Evaluation of the correlation between vitamin D deficiency and presence and severity of anxiety, stress and depressive symptoms. |
Outcome results
None listed