Psychiatric DisorderPhase 1/2NCT06458686
Effect of Vitamin D Supplementation on Mental Health: An Exploratory Study on A University Students Suffering From Vitamin D Deficiency
A Phase 1/2 study testing Vit D in people with Psychiatric Disorder, run by German University in Cairo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 22 years
- Conditions the study is for
- Psychiatric Disorder
- What is being tested?
- Vit D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2024to 30 Sep 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 22 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Being tested
- Vit D, Placebo
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vit DDrug
Vitamin D is a fat soluble vitamin used for the treatment of many diseases.
PlaceboOther
Placebo is a non drug formulation
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | This group does not take any drug. It will take placebo. Receives: Other: Placebo |
| Intervention group | Active comparator | This group will take Vitamin D Receives: Drug: Vit D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start30 Jun 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German University in Cairo
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Mohamed Hassan Solayman, Clinical pharmacy Department, German University in Cairo, Ain Shams University
- Responsible party
- Principal investigator, Nouran Hussien Kandeel, German University in Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458686
- Sponsor's protocol ID
- 1234
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation on Mental Health: An Exploratory Study on A University Students Suffering From Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT06458686
- Acronym / sponsor ID
- 1234
- Conditions
- Psychiatric Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- German University in CairoUniversity, hospital or other
- Collaborators
- Prof. Mohamed Hassan Solayman, Clinical pharmacy Department, German University in Cairo, Ain Shams University
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: PlaceboThis group does not take any drug. It will take placebo. |
| Intervention group | Active comparator | Drug: Vit DThis group will take Vitamin D |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- Hypersensitivity to oral vitamin D supplements such as Diviton or Vidrop.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vit DVitamin D is a fat soluble vitamin used for the treatment of many diseases. | Drug | Intervention group |
| PlaceboPlacebo is a non drug formulation | Other | Control group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vit D in people with Psychiatric Disorder, run by German University in Cairo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the correlation between vitamin D deficiency and presence and severity of anxiety, stress and depressive symptoms. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.