Protocol summary

Summary
The present study was conducted to investigate the effect of vitamin D Mega-dose supplementation on various aspects of physical and mental health of adolescent girls in Mashhad and Sabzevar Cities. The study population included 988 adolescent girls that took 9 Pearls of vitamin D during 9 weeks. Each tablet contains 50000IU vitamin D. inclusion criterion included adolescent girls with age of between 12 to 18 years; also exclusion criteria included history of chronic diseases, cancer or using of drugs and supplements. Samples of fasting blood, urine and stool were taken in the morning at baseline and after one week of 9 weeks intervention. Validated questionnaires are used for assessment of other variables. serum levels of vitamin D, inflammatory markers, blood glucose, lipid profile, liver and kidney function tests, demographic information, medical history status, sun exposure, use of sunscreen, anthropometric factors, gastrointestinal micro biome, dietary intakes and dietary patterns, dietary habits, physical activity, sleep disorders, Cognitive abilities, quality of life, feel of pain, blood pressure, depression and aggression, irritable bowel syndrome, menstrual disorder and polymorphisms of genes related to vitamin D were assessed before and after of vitamin D supplementations. The ethical committee of Mashhad University of Medical Sciences approved the study, and informed written consent was obtained from all participants.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201509047117N7
Registration date: 2015-11-25, 1394/09/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-11-25, 1394/09/04
Registrant information
Name
Majid Ghayour Mobarhan
Name of organization / entity
Mashhad University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 51 1822 8573
Email address
ghayourm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical SciencesVice chancellor for health, Mashhad University of Medical SciencesVice chancellor for research, sabzavar University of Medical SciencesVice chancellor for health, sabzavar University of Medical Sciences
Expected recruitment start date
2015-01-30, 1393/11/10
Expected recruitment end date
2015-05-31, 1394/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of vitamin D supplementation on different aspects of physical and mental health in adolscent girls
Public title
Effects of vitamin D supplementation on different aspects of health
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: student girls with age of between 12 to 18 years exclusion criteria: chronic disease, cancer, drugs and supplements use
Age
From 12 years old to 18 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 988
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad. Doctoral Crossroads. Mashhad university of medical science
City
mashhad
Postal code
Approval date
2015-02-04, 1393/11/15
Ethics committee reference number
4178418

Health conditions studied

1

Description of health condition studied
irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome

2

Description of health condition studied
depression
ICD-10 code
F32
ICD-10 code description
Depressive episode

3

Description of health condition studied
aggression
ICD-10 code
F39
ICD-10 code description
Unspecified mood [affective] disorder

4

Description of health condition studied
quality of life
ICD-10 code
Z00.4
ICD-10 code description
General psychiatric examination, not elsewhere classified

5

Description of health condition studied
Menstrual pattern
ICD-10 code
N94.9
ICD-10 code description
Unspecified condition associated with female genital organs and menstrual cycle

6

Description of health condition studied
dietary intake and dietary pattern
ICD-10 code
E90
ICD-10 code description
Nutritional and metabolic disorders in diseases classified elsewhere

7

Description of health condition studied
Sleep disorders
ICD-10 code
G47
ICD-10 code description
Sleep disorders

8

Description of health condition studied
Vitamin D deficiency
ICD-10 code
E55
ICD-10 code description
Vitamin D deficiency

9

Description of health condition studied
pain
ICD-10 code
F45.4
ICD-10 code description
Persistent somatoform pain disorder

Primary outcomes

1

Description
serum of vitamin d
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
ECL

2

Description
irritable bowel syndrome
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
Rome 3 questionaire

3

Description
depression
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
beck questionaire

4

Description
aggression
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
questionare

5

Description
Menstrual pattern
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
questionare

6

Description
anthropometeric factors
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
anthropometeric tools

7

Description
blood pressure
Timepoint
Before the intervention, one week after the end of intervention.
Method of measurement
Barometer

8

Description
lipid profile
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
autoanalyzer

9

Description
Sleep disorders
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
questionare

10

Description
dietary intake and dietary pattern
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
FFQ, food record

11

Description
liver function
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
ELISA, autoanalyzer

12

Description
kidney function
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
autoanalyzer

13

Description
fasting blood sugar
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
autoanalyzer

14

Description
pain
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
questionare

15

Description
quality of life
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
questionare

16

Description
inflammatory factors
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
autoanalyzer, ELIZA

17

Description
polymorphism
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
taqman, RFLP

18

Description
gut microbiome
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
test of stool sample

19

Description
physical activity
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
پرسشنامه

20

Description
demographic informmation
Timepoint
Before the intervention, A week after the end of 3 months of intervention
Method of measurement
questionaaire

Secondary outcomes

empty

Intervention groups

1

Description
vitamin d, 50000IU, once per ten days for three month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Health center of khorasan razavi
Full name of responsible person
Sayyed Saeid Khayyatzadeh
Street address
Department of New Sciences and Technology, Faculty of Medicine, Mashhad University of Medical science, Azadi square, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of mashhad university of medical science
Full name of responsible person
Keyhan Gonoodi
Street address
Department of New Sciences and Technology, Faculty of Medicine, Mashhad University of Medical science, Azadi square, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of mashhad university of medical science
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Vice Chancellor for health of mashhad university of medical science
Full name of responsible person
Zahra Abasalti
Street address
Department of New Sciences and Technology, Faculty of Medicine, Mashhad University of Medical science, Azadi square, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for health of mashhad university of medical science
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

3

Sponsor
Name of organization / entity
Sabzevar university of medical science
Full name of responsible person
Mohammad Mohammadzadeh
Street address
sabzevar university of medical science, asadabadi street, sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar university of medical science
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad university of medical sicence
Full name of responsible person
Sayyed Saeid Khayyatzadeh
Position
Phd student of nutrition
Other areas of specialty/work
Street address
Department of New Sciences and Technology, Faculty of Medicine, Mashhad University of Medical science, Azadi square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 2882 9260
Fax
Email
khayyatzadehs921@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad university of medical sicence
Full name of responsible person
Majid Ghayour Mobarhan
Position
professor
Other areas of specialty/work
Street address
Department of New Sciences and Technology, Faculty of Medicine, Mashhad University of Medical science, Azadi square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3882 9260
Fax
Email
ghayourm@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad university of medical science
Full name of responsible person
Sayyed Saeid Khayyatzadeh
Position
Phd student of nutrition
Other areas of specialty/work
Street address
Department of New Sciences and Technology, Faculty of Medicine, Mashhad University of Medical science, Azadi square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3882 9260
Fax
Email
khayyatzadehs921@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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