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Evaluation of the efficacy of low-fat dairy products fortified with encapsulated vitamin D on on biochemical markers of liver, kidney and cardiovascular system functions

Protocol summary

Study aim
Evaluation of efficacy of low-fat dairy products fortified with Nano-encapsulated vitamin D on biochemical markers in adults aged 18 to 65 in Mashhad
Design
The parallel, double-blinded, and randomised phase 3 clinical trial including control group was conducted on 280 adults.
Settings and conduct
The study is a randomized, double-blind clinical trial (therapist and patient are not aware about type of medicine). fortified low-fat dairy products, containing encapsulated vitamin D (1500IU), will be prepared in reliable dairy factory. 280 adlults, who lived in Mashhad, will participate in the trial. In this project, individuals are randomly divided into 2 control group and 2 intervention groups. All of the groups complete general information questionnair including demographic information, history of any diseases, and current treatments before starting the trial. ٍEach control group receive one non-fortified dairy product (milk or yogurt) and in each intervention group, one of the products (milk or yogurt) is fortified with vitamin D. Intervention will be considered for 2.5 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria inculded aged between 18 to 65; having consent for participation in study Exclusion criteria inculded Not taking any vitamin D supplements three months before the study; not having Chronic Liver Diseases, Cystic Fibrosis, Crohn's, and Sprue
Intervention groups
Control group receiving non-fortified milk. Intervention group receiving daily milk which is fortified with encapsulated vitamin D (1500 IU). Control group receiving non-fortified yogurt. Intervention group receiving daily yogurt which is fortified with encapsulated vitamin D (1500 IU).
Main outcome variables
Bone density, anthropometric factors, blood pressure, biochemical state, depression, eating habits

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101130005280N27
Registration date: 2019-03-09, 1397/12/18
Registration timing: registered_while_recruiting

Last update: 2019-03-09, 1397/12/18
Update count: 0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of low-fat dairy products fortified with encapsulated vitamin D on on biochemical markers of liver, kidney and cardiovascular system functions
Public title
Evaluation of vitamin D efficacy on biochemical markers
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
aged between 18 to 65 having full consent for participation in trial
Exclusion criteria:
not taking any vitamin D supplement in the last three months before the trial not having Chronic Liver Diseases, Cystic Fibrosis, Crohn's, and Sprue
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 280
Randomization (investigator's opinion)
Randomized
Randomization description
280 adults were divided into two groups of intervention and two control groups through stratified block randomization by using the numbered, sealed and stapled envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
According to the double-blind study, blinding is done for participants and researchers for the intervention and control group. The intervention and control groups are quite similar in terms of appearance, taste and smell and only intervention groups will contain 1,500 international units of nano encapsulated vitamin D.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of National Institute for Medical Research Development
Street address
National Institute for Medical Research Development, No 21, Besat Ave, West Dr. Fatemi Ave
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Approval date
2017-07-15, 1396/04/24
Ethics committee reference number
IR.NIMAD.REC.1396.027

Health conditions studied

1

Description of health condition studied
Vitamin D Deficiency
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Bone Density
Timepoint
Baseline, 75th day
Method of measurement
BMD Method

2

Description
Anthropometric factors
Timepoint
Baseline, 75th day
Method of measurement
using standard scales for weight and height measurement

3

Description
Blood pressure
Timepoint
Baseline, 75th day
Method of measurement
Systolic and diastolic blood pressure measurement

4

Description
Depression
Timepoint
Baseline, 75th day
Method of measurement
Beck depression assessment

5

Description
Eating habits
Timepoint
baseline
Method of measurement
FFQ

6

Description
biochemical state
Timepoint
Baseline, 75th day
Method of measurement
Blood test

Secondary outcomes

empty

Intervention groups

1

Description
First control group: 70 adults receive 200 ml of daily non-fortified milk for 2.5 months
Category
Lifestyle

2

Description
Intervention group: 70 adults receive 200 ml daily milk fortified with encapsulated vitamin D (1500 IU), for 2.5 months.
Category
Lifestyle

3

Description
Second control group: 70 adults receive 100 ml of daily non-fortified yogurt for 2.5 months.
Category
Lifestyle

4

Description
Intervention group: 70 adults receive 100 ml daily yogurt fortified with encapsulated vitamin D (1500 IU), for 2.5 months.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad Faculty Of Medicine
Full name of responsible person
Majid Ghayour-Mobarhan
Street address
Faculty of Medicine, Azadi Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9260
Email
ghayourm@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
National Institute for Medical Research Development
Full name of responsible person
Reza Malek Zadeh
Street address
National Institute for Medical Research Development, No 21, Besat Ave, West Dr. Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
1419693111
Phone
+98 21 6693 8037
Email
NIMAD@RESEARCH.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development
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
Mashhad University of Medical Sciences
Full name of responsible person
Payam Sharifan
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
Faculty of Medicine, Azadi Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9260
Email
Sharifanp961@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-Mobarhan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Medicine, Azadi Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9260
Email
ghayourm@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Payam Sharifan
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
Faculty of Medicine, Azadi Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9260
Email
Sharifanp961@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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