Clinical trial NCT06458686: Effect of Vitamin D Supplementation on Mental Health: An Exploratory Study on A University Students Suffering From Vitamin D Deficiency
Official title: Effect of Vitamin D Supplementation on Mental Health: An Exploratory Study on A University Students Suffering From Vitamin D Deficiency
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Psychiatric Disorder
Lead sponsor: German University in Cairo
Sponsor class: OTHER
Collaborators: name: Prof. Mohamed Hassan Solayman, Clinical pharmacy Department, German University in Cairo
name: Prof. May Ahmed Shawki, Clinical Pharmacy Department, Ain Shams University, Egypt
First posted: 2024-06-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the correlation between vitamin D deficiency and presence and severity of anxiety, stress and depressive symptoms.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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