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The Effects of Vitamin D and Probiotic Co-Supplementation on metabolic syndrome components in the military personnel with this syndrome

Protocol summary

Study aim
Determining the effect of vitamin D supplementation and probiotic supplementation on the components of metabolic syndrome in soldiers with metabolic syndrome and using the results of this plan to use vitamin D and probiotic in the treatment of metabolic syndrome
Design
Intervention trial with control group and intervention group with factorial groups, double-blind, randomized, phase 4, on 60 patients,
Settings and conduct
People referring to the clinic of Khorram Aذad Army Hospital، are researchers and participants in the blind study
Participants/Inclusion and exclusion criteria
Inclusion criteria: Metabolic syndrome according to IDF criteria Inclusion criteria: having a history of cardiovascular disease, liver and kidney failure, kidney, alcohol and smoking, pregnant women, taking probiotic or vitamin D supplements in the last three months
Intervention groups
One of the groups of vitamin D for Perl 50,000 units a week number (for 8 weeks), with capsules of probiotics day one capsule (8 weeks) will be given to groups versus placebo for them, for Pearl One a week or one capsule a day will be prescribed
Main outcome variables
Systolic and diastolic blood pressure, HDL cholesterol, triglycerides, fasting blood sugar, waist size,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180201038585N7
Registration date: 2020-10-27, 1399/08/06
Registration timing: registered_while_recruiting

Last update: 2020-10-27, 1399/08/06
Update count: 0
Registration date
2020-10-27, 1399/08/06
Registrant information
Name
Karim Parastouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 3516
Email address
parastouei@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Vitamin D and Probiotic Co-Supplementation on metabolic syndrome components in the military personnel with this syndrome
Public title
The Effects of Vitamin D and Probiotic on metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-50 years With metabolic syndrome according to IDF criteria
Exclusion criteria:
Having a history of cardiovascular disease Hepatic and renal failure Alcohol and smoking pregnant women Use a probiotic supplement or vitamin D in the last three months
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed by block randomization method which were matched by age an sex. Random sequence generation was done using table of random numbers by a third trained person. Allocation concealment was performed using sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Intervention and assignment was performed by a third trained non-investigator person. The investigator and the participants were not aware of the allocation and will remain the same till the end of the study.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of bahgeyatlah University of Medical Sciences
Street address
Sheykh Bahaei Ave, Molasadra Ave Vanak Square, Mulla Sadra St., South Sheikh Baha'i St.
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-08-19, 1399/05/29
Ethics committee reference number
IR.BMSU.REC.1399.330

Health conditions studied

1

Description of health condition studied
Metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome

Primary outcomes

1

Description
Components of Metabolic Syndrome
Timepoint
At the beginning of the study and 56 days after weekly intake of vitamin D and daily probiotic capsules
Method of measurement
Using height and weight measuring instruments and meters and special test kits

Secondary outcomes

1

Description
Components of Metabolic Syndrome
Timepoint
At the beginning of the study and 56 days after the intervention
Method of measurement
Using height and weight measuring instruments and meters and special test kits

Intervention groups

1

Description
Intervention group: Intervention group: 8 weeks receiving Perl 50,000 units of vitamin D once a week and probiotic capsules once a day
Category
Treatment - Drugs

2

Description
Control group: 8 weeks receiving placebo (placebo) Pearl Vitamin D once a week and probiotic capsule placebo once a day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khorramabad Army Hospital Clinic
Full name of responsible person
Hamze Kakavand
Street address
Badrabad
City
Khorramabad
Province
Lorestan
Postal code
6914147631
Phone
+98 66 3347 0526
Email
hamzekakavand96@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim parastouei
Street address
South Sheikh Bahai St,Mollasadra Ave, Vanak Sq, Tehran
City
Tehran
Province
Tehran
Postal code
912700255
Phone
+98 21 8804 0060
Email
parasstouei@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
karim parastouei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mullasadra Ave, Vannak Sq,Tehran
City
Tehran
Province
Tehran
Postal code
9125007002
Phone
+98 21 8248 3516
Email
parastouei@bmsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim Parastouei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mullasadra Ave, Vannak Sq, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
parastouei@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Karim Parastouei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Mullasadra Ave, Vannak Sq, Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3264
Fax
+98 21 8862 0842
Email
parastouei@bmsu.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
All data can be shared after identifying individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published.
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Statistical analysis is allowed on the documents and can be used after the data is published.
From where data/document is obtainable
En Email the project executor. parastouei@bmsu.ac.ir
What processes are involved for a request to access data/document
After receiving the email, the documents will be sent to the person within a maximum of one week.
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