Effect of Vitamin D Supplementation on Mental Health: An Exploratory Study on A University Students Suffering From Vitamin D Deficiency
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vit D, Placebo.
- Who it may be relevant to
- Registry conditions: Psychiatric Disorder. Basic parameters: 18 years — 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Vit D
Vitamin D is a fat soluble vitamin used for the treatment of many diseases. - Other Placebo
Placebo is a non drug formulation
Primary outcome measures
- Evaluation of the correlation between vitamin D deficiency and presence and severity of anxiety, stress and depressive symptoms. [Time frame: 3 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06458686 · 1234