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

Phase 1

Not yet recruiting

• Conditions: Psychiatric Disorder
• Interventions: Drug: Vit D; Other: Placebo

• Registration Number: NCT06458686
• Lead Sponsor: German University in Cairo

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-09
• Study First Submitted QC: 2024-06-09
• Last Update Submitted: 2024-06-09
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13
• Study Start: 2024-06-30
• Primary Completion: 2026-06-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Vit D	This group will take Vitamin D
Control group	Placebo	This group does not take any drug. It will take placebo.

Primary Outcome Measures

Name	Time	Method
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.