The Effect of Vitamin D3 on Quality of Life and Symptoms of patients with Irritable Bowel Syndrome and vitamin D3 Deficiency
Design
In this study, 50 patients with irritable bowel syndrome participated. These patients receive 300,000 units of vitamin D intramuscularly. The clinical trial phase of this study is 2-3. In this study, the questionnaire of irritable bowel symptoms and quality of life of patients is completed and measured before the intervention and 4 weeks after the injection of vitamin D.This study has no control group.
Settings and conduct
The study site is Arak University of Medical Sciences. First, the symptoms of irritable bowel syndrome, patients' quality of life, and their vitamin D levels are measured. They enter the study if they have the conditions to study. These patients receive 300,000 units of vitamin D intramuscularly. At the end of the 4-week intervention phase, the rate of irritable bowel symptoms and quality of life of patients are measured and the effectiveness of vitamin D is compared with before the intervention.
Participants/Inclusion and exclusion criteria
Patients with irritable bowel syndrome with vitamin D levels between 15 and 30 ng / ml are included in the study. These patients should not have had bowel surgery. If a participant becomes allergic to vitamin D during the study or is unable to continue the study, he or she will be excluded.
Intervention groups
Intervention group: Vitamin D3 (calciferol) in the amount of 300,000 units is administered intramuscularly for this group.
Main outcome variables
Gastrointestinal symptoms and irritable bowel syndrome; Quality of life of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180617040114N4
Registration date:2020-12-16, 1399/09/26
Registration timing:retrospective
Last update:2020-12-16, 1399/09/26
Update count:0
Registration date
2020-12-16, 1399/09/26
Registrant information
Name
jamal Amri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
jamal.amri71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-26, 1399/02/07
Expected recruitment end date
2020-12-09, 1399/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Vitamin D3 on Quality of Life and Symptoms of patients with Irritable Bowel Syndrome and vitamin D3 Deficiency
Public title
The effect of vitamin D3 on the symptoms of patients with irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Vitamin D levels between 15-30 ng/ml
Absence of any gastrointestinal surgery
Lack of severe mental and behavioral disorders
Patients with irritable bowel syndrome according to the diagnosis of a gastroenterologist according to ROME-III criteria
Exclusion criteria:
Consumption a vitamin D supplement one year before enrollment.
Consumption of nicotine and its derivatives in the last 6 months
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:
50
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 Arak University of Medical Sciences
Street address
Aral University of Medical Sciences,Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-04-25, 1399/02/06
Ethics committee reference number
IR.ARAKMU.REC.1399.027
Health conditions studied
1
Description of health condition studied
Patients with irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
Degree of gastrointestinal symptoms and irritable bowel syndrome
Timepoint
It is measured one day before the intervention and 4 weeks after the intervention
Method of measurement
Using Extra-intestinal symptoms severity scale questionnaire
2
Description
Quality of life in patients with irritable bowel syndrome
Timepoint
It is measured one day before the intervention and 4 weeks after the intervention
Method of measurement
Using a quality of life questionnaire for patients with irritable bowel syndrome
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this study are given an intramuscular injection of vitamin D. Its dose is 300,000 units. After 4 weeks of injection, patients' quality of life and the degree of gastrointestinal symptoms and irritable bowel syndrome are measured.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir al-Mo'menin Hospital in Arak
Full name of responsible person
Mohammad Reza Rouhani
Street address
Arak, Sardasht Square, Amir Al-Momenin Hospital
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
it-amiralmomenin@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Leila Savarsfly
Position
Residency
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
Leila.saavar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Reza Rouhani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
mohmadreza.rohani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Leila Savarsfly
Position
Residency
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Arak University of Medical Sciences,Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
name@domian.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
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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