Effect of Vitamin D Supplementation on Mental Health: An Exploratory Study on A University Students Suffering From Vitamin D Deficiency

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-22
SponsorGerman University in Cairo

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vit D

    Drug

    Vitamin D is a fat soluble vitamin used for the treatment of many diseases.

  • Placebo

    Other intervention

    Placebo is a non drug formulation

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Control groupPlacebo comparator 1 intervention
Group B: Intervention groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Evaluation of the correlation between vitamin D deficiency and presence and severity of anxiety, stress and depressive symptoms.

Evaluation of the correlation between vitamin D deficiency and presence and severity of anxiety, stress and depressive symptoms.

Time frame
3 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

German University in Cairo

Lead sponsor

Prof. Mohamed Hassan Solayman, Clinical pharmacy Department, German University in Cairo

Collaborator

Prof. May Ahmed Shawki, Clinical Pharmacy Department, Ain Shams University, Egypt

Collaborator

This trial is not recruiting at the moment. You can still explore other options: