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

NCT06458686 | Not Yet Recruiting Phase 1

• 1 other identifier: 1234
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

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.

  3 months

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Other: Placebo

Intervention group

ACTIVE COMPARATOR

This group will take Vitamin D

Drug: Vit D

Interventions

Vit D DRUG

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

Intervention group

Placebo OTHER

Placebo is a non drug formulation

Control group

Eligibility Criteria

• Age: 18 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nouran hussien kandeel

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 13, 2024
• Study Start: June 30, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 13, 2024

Record last verified: 2024-06