- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Dhaka, 방글라데시
- Bangladesh Medical University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: pre vitamin D group
Pre vitamin D group will be administered vitamin D 50000IU per week for 8 weeks
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No added oral vit D supplimentation
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다른: Post vitamin D group
QEEG will be performed on Post vitamin D group
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No added oral vit D supplimentation
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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vitamin D
기간: 8 weeks
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changes in vitamin D level
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8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Brain wave
기간: 8 weeks
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changes in brain wave pattern
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8 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Dr.Shamima Sultana, MBBS, MD
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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