IRCT | The effect of vitamin D and probiotic co-supplementation on Brain derived neurotrophic factor (BDNF), High sensitive C reactive protein (hs-CRP) ,depressive disorder ,quality of life and sleep in nurses with depressive disorder ; A double-blind randomized controlled clinical trial.

Protocol summary

Study aim: 1- Determining and comparing the average serum vitamin D levels in the intervention and control groups before and after the study 2- Determining and comparing Brain derived neurotrophic factor (BDNF) levels in the intervention and control groups, before and after the study. 3- Determining and comparing the mean High sensitive C reactive protein (hs-CRP) in the intervention and control groups, before and after the study. 4- Determining and comparing the average depression score in the intervention and control groups, before and after the study. 5- Determining and comparing the average quality of life score in the intervention and control groups, before and after the study. 6- Determining and comparing the average sleep quality score in the intervention and control groups, before and after the study.
Design: double-blind randomized controlled clinical trial
Settings and conduct: At Amir al-Momenin Hospital in Shahreza, for 12 weeks, the intervention group received a daily Biozen capsule from Tekgene Pharma Company after lunch or dinner, and the control group received a placebo that was similar in shape, smell, and taste to the intervention group's supplement and contained maltodextrin and was from the same company.
Participants/Inclusion and exclusion criteria: Inclusion criteria: People with mild to severe depressive disorder. People who agree to participate in the study. Age 20-55 years. Exclusion criteria: Following a specific diet (vegetarian diet affecting intestinal flora)
Intervention groups: 70 nurses with depressive disorder were randomly divided into two intervention groups (receiving one Biozen D supplement daily) and a control group (receiving a placebo containing maltodextrin).
Main outcome variables: Serum vitamin D concentration Depression score Quality of life score Sleep quality score Serum BDNF level Serum High sensitive C reactive protein (hs-CRP) level

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20180818040827N7

Registration date: 2025-09-08, 1404/06/17

Registration timing: retrospective

Last update: 2025-09-08, 1404/06/17

Update count: 0
Registration date: 2025-09-08, 1404/06/17

Registrant information: Name

Reza Amnai

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 31 3668 1378

Email address

r_amani@nutr.mui.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2025-08-10, 1404/05/19
Expected recruitment end date: 2025-08-10, 1404/05/19
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effect of vitamin D and probiotic co-supplementation on Brain derived neurotrophic factor (BDNF), High sensitive C reactive protein (hs-CRP) ,depressive disorder ,quality of life and sleep in nurses with depressive disorder ; A double-blind randomized controlled clinical trial.

Public title: The investigation effect of vitamin D and probiotic co-supplementation on depressive disorder
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

People with mild to severe depressive disorder Individuals who agree to participate in the study Age 20 -55 years

Exclusion criteria:

Following specific diets (vegetarian diet affects intestinal flora)
Age: From 20 years old to 55 years old
Gender: Both

Phase

1-2

Groups that have been masked

Participant
Care provider
Investigator

Sample size

Target sample size: 70

Randomization (investigator's opinion)

Randomized

Randomization description

In this study, 70 nurses working in hospitals and having mild to severe depressive disorder scores according to the Beck depression inventory questionnaire (BDI) and according to the inclusion criteria will be included in the study. Individuals will be randomly divided into 2 groups (intervention and control). The randomization method will be performed using Stratified block randomization using blocks of 6 based on the gender variable. To allocate the intervention in the above-mentioned manner, the reliable website https://www.sealedenvelope.com/simple_randomiser/v1/lists will be used. It is worth noting that participants and outcome assessors will not be aware of the patient grouping and will be blinded to it.

Blinding (investigator's opinion)

Double blinded

Blinding description

To allocate the intervention in the above-mentioned manner, the reliable website https://www.sealedenvelope.com/simple_randomiser/v1/lists will be used. It is worth noting that participants and outcome assessors will not be aware of the patient grouping and will be blinded to it

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ehics commitee of Isfahan University of Medical Sciences

Street address

Pasdaran Street, Amir-ol-Momenin Hospital, Shahreza

City

Shahreza

Province

Isfehan

Postal code

8617743111
Approval date: 2025-06-06, 1404/03/16
Ethics committee reference number: IR.MUI.PHANUT.REC.1404.028

Health conditions studied

1

Description of health condition studied: Depressive disorder
ICD-10 code: F33.0
ICD-10 code description: Major depressive disorder, recurrent, mild

2

Description of health condition studied: Depressive disorder
ICD-10 code: F33.1
ICD-10 code description: Major depressive disorder, recurrent, moderate

3

Description of health condition studied: Depressive disorder
ICD-10 code: F33.2
ICD-10 code description: Major depressive disorder, recurrent severe without psychotic features

Primary outcomes

1

Description: Determining and comparing the average serum vitamin D levels in the intervention and control groups before and after the study.
Timepoint: Before the start of the intervention and at the end of the intervention (after week 12)
Method of measurement: Assay kit

Secondary outcomes

1

Description: Determination and comparison of Brain derived neurotrophic factor (BDNF) levels in the intervention and control groups, before and after the study.
Timepoint: Before and after intervention
Method of measurement: Assay kit

2

Description: Determining and comparing the mean High sensitive C reactive protein (hs-CRP) in the intervention and control groups, before and after the study.
Timepoint: Before and after intervention
Method of measurement: Assay kit

3

Description: Determining and comparing the average depression score in the intervention and control groups, before and after the study.
Timepoint: Before and after intervention
Method of measurement: Beck depression inventory questionnaire (BDI)

4

Description: Determining and comparing the average quality of life score in the intervention and control groups, before and after the study.
Timepoint: Before and after intervention
Method of measurement: World Health Organization 26-item Quality of Life Questionnaire

5

Description: Determining and comparing the average sleep quality score in the intervention and control groups, before and after the study.
Timepoint: Before and after intervention
Method of measurement: Pittsburgh Sleep Quality Questionnaire

Intervention groups

1

Description: Intervention group: This group received a Biozen supplement containing 400IU of vitamin D and a probiotic containing 109×2CFU of each of the species Bacillus coagulans, Lactobacillus rhamnosus, Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus acidophilus, and Bifidobacterium bifidum for 12 weeks.
Category: Treatment - Drugs

2

Description: Control group: This group receives a placebo supplement of Biozen Which contains maltodextrin for 12 weeks.
Category: Treatment - Drugs

Recruitment centers

1

Recruitment center: Name of recruitment center

Amir-Al-Momenin Hospital, Shahreza

Full name of responsible person

Dr. Marzieh Taghvaei

Street address

Shahreza-Pasdaran Street, Amiralmomenin Hospital

City

shahreza

Province

Isfehan

Postal code

8617743111

Phone

+98 31 5313 5000

Email

shahreza_hos@mui.ac.ir

1

Sponsor: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Dr. Gholamreza Askari

Street address

hezar garib St.Isfahan University of Medical Sciences

City

Isfahan

Province

Isfehan

Postal code

81746-73461

Phone

+98 31 3668 8168

Email

askari@mui.ac.ir
Grant name: 538940000
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Esfahan University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Yeganeh Hoveyda

Position

Master's student

Latest degree

Bachelor

Other areas of specialty/work

Nutrition

Street address

Hezar Jerib Street, Isfahan University of Medical Sciences

City

Isfahan

Province

Isfehan

Postal code

8174673461

Phone

+98 31 3792 3175

Email

hoveyda.yeganeh77@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Dr.Reza Amani

Position

professor

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

Hezar Jerib Street, Isfahan University of Medical Sciences

City

Isfahan

Province

Isfehan

Postal code

8174673461

Phone

+98 31 3792 3175

Email

r_amani@nutr.mui.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Esfahan University of Medical Sciences

Full name of responsible person

Dr.Reza Amani

Position

Professor

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

Hezar Jerib Street, Isfahan University of Medical Sciences

City

Isfahan

Province

Isfehan

Postal code

8174673461

Phone

+98 31 3792 3157

Email

r_amani@nutr.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: Magor part of information will be available for population
When the data will become available and for how long: 12 months after publication
To whom data/document is available: Available for people working in academic institutions
Under which criteria data/document could be used: To conduct similar studies
From where data/document is obtainable: r_amani@nutr.mui.ac.ir
What processes are involved for a request to access data/document: The data will be sent as soon as possible , after receiving the reuest
Comments

The effect of vitamin D and probiotic co-supplementation on Brain derived neurotrophic factor (BDNF), High sensitive C reactive protein (hs-CRP) ,depressive disorder ,quality of life and sleep in nurses with depressive disorder ; A double-blind randomized controlled clinical trial.