Major Depressive Disorder (MDD)NCT07579078
Effect of Vitamin D Supplementation on Brain Waves in Female Major Depressive Disorder Patients With Hypovitaminosis D
A study testing Dietary vitamin D in people with Major Depressive Disorder (MDD) and Hypovitaminosis D, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial summary
Major Depressive Disorder (MDD) is a common mood disorder characterized by persistent sadness, loss of interest and cognitive impairment. Emerging evidence suggests that vitamin D may exert neuroprotective and mood-regulating effects by influencing serotonin synthesis, modulating inflammation and supporting neuronal… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Major Depressive Disorder (MDD), Hypovitaminosis D
- What is being tested?
- Dietary vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBangladesh
- Study dates
- 25 Apr 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • Diagnosed case of MDD by a psychiatrist form the Department of Psychiatry OPD, based on the Diagnostic and Statistical Manual of Mental Disorder, 5th edition (DSM-V) criteria set by the American Psychiatric Association.
- Hypovitaminosis D ( serum 25 ( OH )D <30 ng/ml )
- Age range : 20-40 years
- Sex: female
- Patients must be on a stable dose regimen, without any changes in drug type or dosage, for at least 6 months prior to enrollment , to minimize confounding effects on EEG outcomes.
- Not receiving any medication that affect central nervous system other than anti-depressant drugs
Who cannot join
- Active smokers
- Known hypersensitivity to vitamin D
- Presence of any other serious psychiatric or systemic illness
- Pregnant women
- Lactating women
- Women taking hormonal contraceptives.
- Individuals already taking vitamin D supplements
- Patients with hypercalcemia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Vitamin D Supplementation on Brain Waves in Female Major Depressive Disorder Patients With Hypovitaminosis D : A Quantitative Electroencephalogram Analysis
Major Depressive Disorder (MDD) is a common mood disorder characterized by persistent sadness, loss of interest and cognitive impairment. Emerging evidence suggests that vitamin D may exert neuroprotective and mood-regulating effects by influencing serotonin synthesis, modulating inflammation and supporting neuronal function. Vitamin D deficiency is frequently observed in MDD patients and has been linked to greater symptom severity and poorer treatment outcomes. Quantitative electroencephalography (QEEG) is a non-invasive tool for assessing brain electrical activity. Alterations in QEEG pattern such as increased theta and reduced alpha power have been reported in patients with MDD , reflecting disrupted cortical processing and emotional regulation. Although interest in the role of vitamin D in mental health is increasing, the direct effect of vitamin D supplementation on QEEG parameters in MDD patients with hypovitaminosis D is not well explored. This study aims to evaluate whether vitamin D supplementation can modulate brain wave activity in female patients with MDD and hypovitaminosis D. Therefore providing insight into its neurophysiological and therapeutic significance.
Read the detailed description
Objective To evaluate the effect of vitamin D supplementation on quantitative EEG parameters in female MDD patients with hypovitaminosis D.
Methods This experimental study (self-controlled trial) will be conducted by the Department of Physiology, Bangladesh Medical University, Shahbagh, Dhaka from September 2025- August 2026. For this study, a total number of 39 female patients with MDD (age 20-40 years) will be enrolled as study participants according to selection criteria. DASS-21 scoring and baseline EEG will be recorded (pre vitamin D group). After that the participants will be supplemented vitamin D capsule (50,000IU/week) for 8 weeks. After completion of 8 weeks, DASS-21 scoring and EEG will be recorded and that will be designated as post vitamin D group.
To analyze brain electrical activities, the band power of alpha, beta, theta, and delta brainwaves will be measured using an EEG Data gathering Device, the EEG Traveler BrainTech 32+ CMEEG-01 from India. The BT40 analysis software will be used to perform power spectral analysis of the EEG Data. Mean ± SD will be used to express the Data. For statistical analysis, if data are normally distributed, to compare the mean values between the pre intervention and post intervention sessions, recorded as pre vitamin D group and post vitamin D group, paired- samples t test will be done. The P value of ≤0.05 will be accepted as statistically significant. SPSS for Windows (version 25) will be used for the statistical analysis.
The findings of this study are expected to provide quantitative evidence regarding the neurophysiological effects of vitamin D supplementation in female MDD patients with hypovitaminosis D.
- Conditions
- Major Depressive Disorder (MDD), Hypovitaminosis D
- Being tested
- Dietary vitamin D
- Keywords
- MDD, Vitamin D, QEEG, brain wave
- Medical subject headings
- Depressive Disorder, Major, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary vitamin DDietary supplement
No added oral vit D supplimentation
| Study group | Role | What they receive |
|---|---|---|
| pre vitamin D group | Experimental | Pre vitamin D group will be administered vitamin D 50000IU per week for 8 weeks Receives: Dietary Supplement: Dietary vitamin D |
| Post vitamin D group | Other | QEEG will be performed on Post vitamin D group Receives: Dietary Supplement: Dietary vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
vitamin D
changes in vitamin D level
Measured: 8 weeks
Secondary outcomes (1)
Brain wave
changes in brain wave pattern
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start25 Apr 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naima Ahmed, Bangladesh Medical University
- Investigators
- Dr.Shamima Sultana, MBBS, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579078
- Sponsor's protocol ID
- BMU/2026/2035
- Status last verified
- May 2026
- First submitted
- 30 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation on Brain Waves in Female Major Depressive Disorder Patients With Hypovitaminosis D : A Quantitative Electroencephalogram Analysis
- ClinicalTrials.gov ID
- NCT07579078
- Acronym / sponsor ID
- BMU/2026/2035
- Conditions
- Major Depressive Disorder (MDD), Hypovitaminosis D
- Keywords
- MDD, Vitamin D, QEEG, brain wave
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 25 Apr 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 May 2026 (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.
Major Depressive Disorder (MDD) is a common mood disorder characterized by persistent sadness, loss of interest and cognitive impairment. Emerging evidence suggests that vitamin D may exert neuroprotective and mood-regulating effects by influencing serotonin synthesis, modulating inflammation and supporting neuronal function. Vitamin D deficiency is frequently observed in MDD patients and has been linked to greater symptom severity and poorer treatment outcomes. Quantitative electroencephalography (QEEG) is a non-invasive tool for assessing brain electrical activity. Alterations in QEEG pattern such as increased theta and reduced alpha power have been reported in patients with MDD , reflecting disrupted cortical processing and emotional regulation. Although interest in the role of vitamin D in mental health is increasing, the direct effect of vitamin D supplementation on QEEG parameters in MDD patients with hypovitaminosis D is not well explored. This study aims to evaluate whether vitamin D supplementation can modulate brain wave activity in female patients with MDD and hypovitaminosis D. Therefore providing insight into its neurophysiological and therapeutic significance.
Detailed description
Objective To evaluate the effect of vitamin D supplementation on quantitative EEG parameters in female MDD patients with hypovitaminosis D.
Methods This experimental study (self-controlled trial) will be conducted by the Department of Physiology, Bangladesh Medical University, Shahbagh, Dhaka from September 2025- August 2026. For this study, a total number of 39 female patients with MDD (age 20-40 years) will be enrolled as study participants according to selection criteria. DASS-21 scoring and baseline EEG will be recorded (pre vitamin D group). After that the participants will be supplemented vitamin D capsule (50,000IU/week) for 8 weeks. After completion of 8 weeks, DASS-21 scoring and EEG will be recorded and that will be designated as post vitamin D group.
To analyze brain electrical activities, the band power of alpha, beta, theta, and delta brainwaves will be measured using an EEG Data gathering Device, the EEG Traveler BrainTech 32+ CMEEG-01 from India. The BT40 analysis software will be used to perform power spectral analysis of the EEG Data. Mean ± SD will be used to express the Data. For statistical analysis, if data are normally distributed, to compare the mean values between the pre intervention and post intervention sessions, recorded as pre vitamin D group and post vitamin D group, paired- samples t test will be done. The P value of ≤0.05 will be accepted as statistically significant. SPSS for Windows (version 25) will be used for the statistical analysis.
The findings of this study are expected to provide quantitative evidence regarding the neurophysiological effects of vitamin D supplementation in female MDD patients with hypovitaminosis D.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre vitamin D group | Experimental | Dietary Supplement: Dietary vitamin DPre vitamin D group will be administered vitamin D 50000IU per week for 8 weeks |
| Post vitamin D group | Other | Dietary Supplement: Dietary vitamin DQEEG will be performed on Post vitamin D group |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Diagnosed case of MDD by a psychiatrist form the Department of Psychiatry OPD, based on the Diagnostic and Statistical Manual of Mental Disorder, 5th edition (DSM-V) criteria set by the American Psychiatric Association.
Key exclusion criteria (8 listed)
- Active smokers
- Known hypersensitivity to vitamin D
- Presence of any other serious psychiatric or systemic illness
- Pregnant women
- Lactating women
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 |
|---|---|---|
| Dietary vitamin DNo added oral vit D supplimentation | Dietary supplement | Post vitamin D group, pre vitamin D group |
Primary outcome
vitamin D
Time frame: 8 weeks
changes in vitamin D level
1 secondary outcome
Brain wave
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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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.
Dr.Shamima Sultana, MBBS, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary vitamin D in people with Major Depressive Disorder (MDD) and Hypovitaminosis D, run by Bangladesh Medical University at 1 site in Bangladesh.
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 6 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
vitamin D (time frame: 8 weeks). 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 12 May 2026.