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

Psychiatric Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458686
• Other study ID #: 1234
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: June 30, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: June 2024
• Source: German University in Cairo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: September 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Problem Behavior
• Psychiatric Disorder
• Vitamin D Deficiency

Intervention

Drug:
• Vit D
Vitamin D is a fat soluble vitamin used for the treatment of many diseases.

Other:
• Placebo
Placebo is a non drug formulation

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
German University in Cairo	Prof. May Ahmed Shawki, Clinical Pharmacy Department, Ain Shams University, Egypt, Prof. Mohamed Hassan Solayman, Clinical pharmacy Department, German University in Cairo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months