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

NCT ID: NCT06458686

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2026-09-30

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.

Conditions

Psychiatric Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

This group does not take any drug. It will take placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo is a non drug formulation

Intervention group

This group will take Vitamin D

Group Type: ACTIVE_COMPARATOR

Vit D

Intervention Type: DRUG

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

Interventions

Vit D

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

Intervention Type: DRUG

Placebo

Placebo is a non drug formulation

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

German University in Cairo

OTHER

Sponsor Role: lead

Responsible Party

Nouran Hussien Kandeel

Nouran hussien kandeel

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

1234

Identifier Type: -

Identifier Source: org_study_id