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

G

German University in Cairo

Status and phase

Not yet enrolling
Phase 2
Phase 1

Conditions

Psychiatric Disorder

Treatments

Other: Placebo
Drug: Vit D

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 22 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups, including a placebo group

Control group
Placebo Comparator group
Description:
This group does not take any drug. It will take placebo.
Treatment:
Other: Placebo
Intervention group
Active Comparator group
Description:
This group will take Vitamin D
Treatment:
Drug: Vit D

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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