NCT07579078

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Apr 2026Dec 2026

Study Start

First participant enrolled

April 25, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

April 30, 2026

Last Update Submit

May 8, 2026

Conditions

Keywords

MDDVitamin DQEEGbrain wave

Outcome Measures

Primary Outcomes (1)

  • vitamin D

    changes in vitamin D level

    8 weeks

Secondary Outcomes (1)

  • Brain wave

    8 weeks

Study Arms (2)

pre vitamin D group

EXPERIMENTAL

Pre vitamin D group will be administered vitamin D 50000IU per week for 8 weeks

Dietary Supplement: Dietary vitamin D

Post vitamin D group

OTHER

QEEG will be performed on Post vitamin D group

Dietary Supplement: Dietary vitamin D

Interventions

Dietary vitamin DDIETARY_SUPPLEMENT

No added oral vit D supplimentation

Post vitamin D grouppre vitamin D group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bangladesh Medical University

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Depressive Disorder, MajorVitamin D Deficiency

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Dr.Shamima Sultana, MBBS, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Single
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 11, 2026

Study Start

April 25, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 12, 2026

Record last verified: 2026-05

Locations