Protocol summary

Study aim
Efficacy of Vitamin D on serum levele of visfatin and vascular endothelial growth factor (VEGF) among ulcerative colitis patients.
Design
Clinical randomized trial, stratified blocked randomization, double blinded, sham controlled clinical trial with a parallel group design of 90 patients
Settings and conduct
In this double-blind clinical trial, 90 patients 18 to 50 years old with ulcerative colitis in remission status and medications cyclosporine Anti-TNF-α and also not eat, volunteers will be recruited. Screening is done through referral to hospital records and contact with patients living in Tehran and inviting them to the project. For blinding, the note paper is numbered zero and one in 4-digit blocks and by a person other than the researcher, each time, a paper is accidentally taken out of the paper, which is injected for a zero placebo site and one for vitamin D.
Participants/Inclusion and exclusion criteria
Inclusion criteria for the study: 1- People with a diagnosis of ulcerative colitis clinical examination to assess the colonoscopic biopsy and course of the disease in the medical record and confirmed by a gastroenterologist and liver that are in a state of Remission. 2- People who volunteer to participate in the study 3- Age between 18 to 50 years 4-BMI of 18.5 to 30 Exclusion criteria: 1-People in relapse status 2-Pregnant and lactating women 3-Anti-TNF-α drugs such as Infliximab 4- History of kidney stones and any diseases of the kidney, liver, cancer 5-Background taking any supplements containing vitamin D during the three months prior to the study 6-Diagnosis doctor to not being able to participate in the study
Intervention groups
Treatment group 45 patients with ulcerative colitis in Remission status, receive Single dose of 300,000 IU of vitamin D and the placebo group (45 patients with ulcerative colitis in Remission status) receive 1 cc of normal saline.
Main outcome variables
visfatin and vascular endothelial growth factor (VEGF)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131125015536N7
Registration date: 2018-02-20, 1396/12/01
Registration timing: prospective

Last update: 2018-02-20, 1396/12/01
Update count: 0
Registration date
2018-02-20, 1396/12/01
Registrant information
Name
Mohammad Javad Hosseinzadeh
Name of organization / entity
School of Nutritional Sciences and Dietetics, TUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 3059
Email address
mhosseinzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Vitamin D on serum levele of visfatin and vascular endothelial growth factor (VEGF) among Ulcerative Colitis Patients
Public title
Efficacy of Vitamin D on serum levele of visfatin and vascular endothelial growth factor (VEGF)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with a diagnosis of ulcerative colitis clinical examination to assess the colonoscopic biopsy and course of the disease in the medical record and confirmed by a gastroenterologist and liver that are in a state of Remission People who volunteer to participate in the study Age between 18 to 50 years old BMI of 18.5 to 30
Exclusion criteria:
People in relapse status Pregnant and lactating women Anti-TNF-α drugs such as Infliximab History of kidney stones and any diseases of the kidney, liver, cancer Background taking any supplements containing vitamin D during the three months prior to the study Diagnosis doctor to not being able to participate in the study
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Ninety persons were randomized manually using Stratified Blocked Randomization method. Strata were based on age (≤35 years/>35 years) and BMI (≤25/>25 kg/m2) with blocks of 4.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding, the note paper is numbered zero and one in 4-digit blocks and by a person other than the researcher, each time, a paper is accidentally taken out of the paper, which is injected for a zero placebo site and one for vitamin D.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Sixth Floor-Central Tehran University-Qods St, Keshavarz Blvd, tehran
City
tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-01-28, 1396/11/08
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4365

Health conditions studied

1

Description of health condition studied
Ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis

Primary outcomes

1

Description
serume visfatin
Timepoint
Before and after intervention
Method of measurement
ELISA Kit

2

Description
serume levele of vascular endothelial growth factor (VEGF)
Timepoint
before and after intervention
Method of measurement
ELISA Kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 1 mL 300,000 IU Vitamin D3
Category
Treatment - Drugs

2

Description
1 mL normal saline
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
shariati hospital
Full name of responsible person
Amrollah Sharifi
Street address
International Campus-tehran university of medical science-porsina ave-ghods street-keshavarz blv-tehran
City
tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8895 1395
Email
emami.mohammadreza70@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
معاونت تحقیقات و فن آوری دانشگاه
Street address
Sixth Floor-Central University, Qods St, Keshavarz Blvd, tehran
City
tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8895 5975
Fax
+98 21 8898 4861
Email
Info_snsd@tums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
mohammadreza emami
Position
MSc Student Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of nutritional sciences and dietetics, Tehran University of Medical Sciences, St-hojjat-dost, St-Naderi, St-Enghelab, tehran
City
tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8897 4463
Email
emami.mohammadreza70@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Javad Hosseinzadeh-Attar
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of nutritional sciences and dietetics, Tehran University of Medical Sciences, St-hojjat-dost, St-Naderi St-Enghelab, tehran
City
tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8895 1395
Email
mhosseinzadeh@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
mohammadreza emami
Position
MSc student of nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of nutritional sciences and dietetics,Tehran University of Medical Sciences, St-hojjat-dost, St-Naderi, St-Enghelab, tehran
City
tehran
Province
Tehran
Postal code
1417653761
Phone
+98 910 800 2099
Email
emami.mohammadreza70@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Patient dissatisfaction
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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