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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psychiatric Disorder
• Intervention / Treatment: Other: Placebo; Drug: Vit D

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; This group does not take any drug. It will take placebo.	Other: Placebo; Placebo is a non drug formulation
Active Comparator: Intervention group; This group will take Vitamin D	Drug: Vit D; Vitamin D is a fat soluble vitamin used for the treatment of many diseases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: German University in Cairo
• Collaborators: Prof. Mohamed Hassan Solayman, Clinical pharmacy Department, German University in Cairo; Prof. May Ahmed Shawki, Clinical Pharmacy Department, Ain Shams University, Egypt

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: June 9, 2024
• First Submitted That Met QC Criteria: June 9, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 9, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Problem Behavior; Vitamin D Deficiency; Mental Disorders
• Other Study ID Numbers: 1234 (Department of Defense)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No