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.

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Key information

Conditions

Psychiatric Disorder Mental Disorders

Age range

18 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vit D

Drug

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

Placebo

Other

Placebo is a non drug formulation

Primary outcomes

Evaluation of the correlation between vitamin D deficiency and presence and severity of anxiety, stress and depressive symptoms.

Time frame: 3 months

Evaluation of the correlation between vitamin D deficiency and presence and severity of anxiety, stress and depressive symptoms.

Sponsors and collaborators

Lead sponsor

German University in Cairo

Other

Collaborators

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

Registry information

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Jun 13, 2024
Registry last updated: Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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