- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07579078
Effect of Vitamin D Supplementation on Brain Waves in Female Major Depressive Disorder Patients With Hypovitaminosis D
Effect of Vitamin D Supplementation on Brain Waves in Female Major Depressive Disorder Patients With Hypovitaminosis D : A Quantitative Electroencephalogram Analysis
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Dhaka, Bangladesh
- Bangladesh Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: pre vitamin D group
Pre vitamin D group will be administered vitamin D 50000IU per week for 8 weeks
|
No added oral vit D supplimentation
|
|
Other: Post vitamin D group
QEEG will be performed on Post vitamin D group
|
No added oral vit D supplimentation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
vitamin D
Time Frame: 8 weeks
|
changes in vitamin D level
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain wave
Time Frame: 8 weeks
|
changes in brain wave pattern
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr.Shamima Sultana, MBBS, MD
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BMU/2026/2035
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypovitaminosis D
-
Madigan Army Medical CenterRecruitingHypovitaminosis D | HypovitaminosisUnited States
-
IRCCS San RaffaeleRecruiting
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Silvana De Giorgi; Davide Bizzoca; Angela NotarnicolaRecruitingHypovitaminosis DItaly
-
Hospices Civils de LyonCompleted
-
Jewish General HospitalMcGill UniversityCompleted
-
Boston UniversityCompletedVitamin D Deficiency | Vitamin E Deficiency | Hypovitaminosis AUnited States
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...Completed
-
Massachusetts General HospitalBio-Tech Pharmacal, Inc.CompletedHypovitaminosis DUnited States
-
Chulalongkorn UniversityUnknownVitamin D2 Supplementation in Vitamin D InsufficiencyThailand
-
University Hospital, AngersNot yet recruiting
Clinical Trials on Dietary vitamin D
-
University of BolognaNot yet recruiting
-
Christian PagnouxCompletedMicroscopic Polyangiitis | Granulomatosis With Polyangiitis | Eosinophilic Granulomatosis With Polyangiitis | ANCA-associated VasculitisCanada
-
IIMC, Riphah International University, PakistanNot yet recruitingGestational Diabetes MellitusPakistan
-
Kuang Tien General HospitalRecruitingThe Effects of Vitamin D Plus Omega-3 Polyunsaturated Fatty Acids in Patients With Episodic MigraineEpisodic MigraineTaiwan
-
Rutgers UniversityNational Institute on Aging (NIA)CompletedWeight Loss | Vitamin D or PlaceboUnited States
-
National and Kapodistrian University of AthensNational Hellenic Research FoundationCompletedOsteopenia | Postmenopausal OsteopeniaGreece
-
Bambino Gesù Hospital and Research InstituteCompletedNAFLD | Non Alcoholic Steatohepatitis (NASH)Italy
-
McLennan County Medical Education and Research...Procter and GambleCompletedVitamin D Deficiency | Osteoporosis | OsteopeniaUnited States
-
University of Ilorin Teaching HospitalMayo ClinicNot yet recruitingProstate Cancer (Adenocarcinoma) | Vitamin D on Tumor Response and Inflammatory MarkersNigeria
-
University of North Carolina, Chapel HillNorth Carolina Translational and Clinical Sciences InstituteRecruitingFrailty | Multiple Chronic Conditions | Weakness, MuscleUnited States