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Effects of supplementation with vitamin D on clinical outcomes, quality of life, anxiety, serum CRH and IL-6 in Patient with irritable bowel syndrome the predominant form diarrhea

Protocol summary

Summary
The main purpose: to determine the effect of vitamin D on clinical outcomes, quality of life, stress and anxiety, serum concentrations of CRH and IL-6 in patients with irritable bowel syndrome with predominant form of diarrhea; Study design: Randomized, double-blind, placebo-controlled, single-center, phase II trial; Randomization Details: For randomization, the permuted block randomization will be used with quadruple blocks. According to the sample size of 88, which is set, 22 blocks will be produced using www.sealedenvelope.com. In order to apply the concealment in the randomization process, unique codes will be used on complementary boxes, the code being generated by the software. study population: patients with irritable bowel syndrome with diarrhea admitted to hospital the Prophet (PBUH) Inclusion criteria: age between 18 to 65 years, diagnosed with irritable bowel syndrome with diarrhea forms and questionnaires completed by ROME III criteria for the diagnosis of IBS, their disease severity score is between 175 to 300, BMI is between 18.5 and 34.9, don't have abdominal illness and abdominal surgery, they don't use vitamin D in the last 6 months. Probiotic supplements and do not use antidepressants. Exclusion criteria from the study: the creation of any abnormal response to supplements, gastrointestinal bleeding, blood in the stool, loss weight fast, levels of vitamin D normal (above 30 nmol / L ), taking less than 80 percent complete and wanting person to continue to cooperate. Intervention: Supplementation with vitamin D or a placebo intervention period: 3 months sample size:44 person in each group The primary outcome: improvement of clinical symptoms, disease severity, quality of life and stress and anxiety Secondary outcomes: serum levels of Corticotropin Releasing Hormone and Inter Lukin-6

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201709232709N45
Registration date: 2017-10-04, 1396/07/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-04, 1396/07/12
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Colorectal Research Center of Rasool Akram Hospital
Expected recruitment start date
2017-07-06, 1396/04/15
Expected recruitment end date
2017-11-06, 1396/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of supplementation with vitamin D on clinical outcomes, quality of life, anxiety, serum CRH and IL-6 in Patient with irritable bowel syndrome the predominant form diarrhea
Public title
The effect of vitamin D supplementation on patients with irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria for the study: aged between 18 and 65 years; suffering from irritable bowel syndrome ROME III criteria and completed the questionnaires; their disease severity score is between 175 and 300; BMI Between 18.5 to 34.9; a resident of Tehran; have diarrhea-predominant irritable bowel syndrome with form. Non-inclusion criteria: pregnant women or nursing mothers; a history of gastrointestinal diseases, including IBD, colorectal cancer and...; Gastrointestinal diseases such as celiac disease, is an infection of the gastrointestinal tract and ...; Abdominal surgery or radiation therapy, cholecystectomy, etc. The use of vitamin D supplements, six months before; Use of now any type of supplement or 3 months; probiotic supplement use; Antidepressants uses (Including serotonin receptor antagonists, tricyclic antidepressants, selective serotonin reuptake inhibitors, etc.); High-dose alcohol and caffeine 24 hours before the test; smoking 48 hours before the test; Exclusion criteria: Create any abnormal reactions to supplements; gastrointestinal bleeding; blood in the stool; rapid weight loss; the level of vitamin D normal (above 30 nmol / L); less than 80 percent of supplements; no intention to continue cooperation
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences.
Street address
Iran University of Medical Sciences, next to the Tower and Milad Hospital, Hemmat Highway
City
Tehran
Postal code
Approval date
2017-06-19, 1396/03/29
Ethics committee reference number
IR.IUMS.REC 1396.30232

Health conditions studied

1

Description of health condition studied
Irritable Bowel Syndrome
ICD-10 code
K58.0
ICD-10 code description
Irritable bowel syndrome with diarrhoea

Primary outcomes

1

Description
Clinical signs
Timepoint
Before and after 3 months of intervention
Method of measurement
ROME IV questionnaire and World Gastroenterology Organization questionnaire for the diagnosis of irritable bowel syndrome

2

Description
Severity of Clinical symptoms
Timepoint
Before and after 3 months of intervention
Method of measurement
IBS symptom severity questionnaire.

3

Description
Quality of life
Timepoint
Before and after 3 months of intervention
Method of measurement
Irritable Bowel Syndrome Quality of Life Questionnaire.

Secondary outcomes

1

Description
Anxiety
Timepoint
Before and after 3 months of intervention
Method of measurement
Hospital Anxiety and Depression Scale(HADS)

2

Description
Corticotropin Releasing Hormone
Timepoint
Before and after 3 months of intervention
Method of measurement
Elisea

3

Description
Interlukin-6
Timepoint
Before and after 3 months of intervention
Method of measurement
Elisea

Intervention groups

1

Description
Receiving vitamin D from Zahrawi Company with 50,000 international units weekly in intervention group
Category
Treatment - Drugs

2

Description
Filled with edible paraffin placebo produced by Zahrawi Co. was performed weekly in the control group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Educational Research Center Rasoule Akram Hospital
Full name of responsible person
Marjan Mokhtare
Street address
Educational Research Center Rasoule Akram Hospital, Niayesh street, Shahrara street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research,Iran University of Medical Sciences
Full name of responsible person
Doctor Iraj Alimohammadi
Street address
Iran University of Medical Sciences, next to the Tower and Milad Hospital, Hemmat Highway
City
Tehran
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,Iran University of Medical Sciences
Proportion provided by this source
100
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
Iran University Medical Sceinces
Full name of responsible person
Masoumeh Khalighi Sikaroudi
Position
Student Masters
Other areas of specialty/work
Street address
Iran University of Medical Sciences, next to the Tower and Milad Hospital, Hemmat Highway,
City
Tehran
Postal code
Phone
+98 21 6651 7341
Fax
Email
masoomehkhalighi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University Medical Sciences
Full name of responsible person
Dr Farzad Shidfar
Position
PHD nutrition
Other areas of specialty/work
Street address
Iran University of Medical Sciences, next to the Tower and Milad Hospital, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8670 4711
Fax
Email
masoomehkhalighi@gmail.com; Farzadshidfar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University Medical of Scienses
Full name of responsible person
Masoumeh Khalighi Sikaroudi
Position
Student Masters
Other areas of specialty/work
Street address
Iran University of Medical Sciences, next to the Tower and Milad Hospital, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 8670 4711
Fax
Email
masoomehkhalighi@gmail.com
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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