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Effect of Vitamin D3 Supplementation in Treatment of Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Vitamin D3 (Cholecalciferol)
placebo
Sponsored by
Ahvaz Jundishapur University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, inflammation, oxidative stress, clinical signs, vitamin D3

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patients who are diagnosed with Irritable Bowel Syndrome (IBS) according to ROME III criteria; Signed consent by the patient.

Exclusion Criteria:

  • Patients who have celiac disease (diagnosed by a duodenal biopsy or celiac serological tests)
  • Any other diseases of the gastrointestinal tract such as Inflammatory Bowel Disease (IBD)
  • Any kind of abdominal surgery
  • Chronic disease such as diabetes
  • Cardiovascular, hepatic
  • Kidney and severe infection
  • Pregnancy
  • Breastfeeding
  • Smoking
  • Alcohol consumption
  • Use of dietary supplements
  • Use of vitamin D and calcium supplement during the last year before the study
  • Use any medication for signs improvement during the study period.

Sites / Locations

  • Ahvaz Jundishapur University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D3

placebo

Arm Description

50000 IU vitamin D3 capsule, one capsule every 2 weeks for 6 months.

Placebo capsule, one capsule every 2 weeks for 6 months.

Outcomes

Primary Outcome Measures

Clinical signs including abdominal pain, bloating, rumbling, abdominal distention, dissatisfaction with stool consistency
clinical signs will be assessed by Visual Analog Scale (VAS) 0-100mm self-report questionnaire at baseline and every two weeks for six months.
Symptom Severity Score
symptom severity score will be assessed by IBS-Symptom Severity Score (IBS-SSS) self-report questionnaire baseline and after six months intervention.

Secondary Outcome Measures

Dietary intake
24-Hour dietary recalls questionnaires will be used to assess dietary pattern at baseline and after 3 and 6 months intervention.
Body Weight
Body Weight will be measured in kilograms at baseline and after six months intervention.
Body Mass Index (BMI)
BMI is weight in kilograms divided to height in meters squared. It will be measured at baseline and after six months intervention.
Waist Circumference (WC)
WC will be measured in centimeter at baseline and after six months intervention.
Hip Circumference (HC)
HC will be measured in centimeter at baseline and after six months intervention.
Waist to Hip Ratio (WHR)
WHR is WC divided to HC. It will be measured at baseline and after six months intervention.
Blood Pressure (BP)
BP will be measured in mmHg at baseline and after six months intervention.
Health-related Quality of Life
Health-Related Quality of Life will be assessed by IBS-Quality Of Life (IBS-QOL) with 34-item Short-Form (SF-34) self-report questionnaire at baseline and after six months intervention.
Tumor Necrosis Factor-α (TNF-α)
Blood serum TNF-α will be assessed by enzyme-linked immunosorbent assay (ELISA) at baseline and after six months intervention.
Interleukin-10 (IL-10)
Blood serum IL-10 will be assessed by ELISA at baseline and after six months intervention.
Interleukin-17 (IL-17)
Blood serum IL-17 will be assessed by ELISA at baseline and after six months intervention.
Malondialdehyde (MDA)
Blood serum MDA will be assessed by Thiobarbituric acid (TBA) method at baseline and after six months intervention.
Total Antioxidant Capacity (TAC)
Blood serum TAC will be assessed by Ferric Reducing Antioxidant Power (FRAP) assay at baseline and after six months intervention.
25-hydroxy vitamin D (25(OH)D)
Blood serum 25(OH)D will be assessed by Radioimmunoassay at baseline and after six months intervention.
Calcium
Blood serum Calcium will be assessed by Arsenazo III method at baseline and after six months intervention

Full Information

First Posted
October 11, 2015
Last Updated
November 27, 2015
Sponsor
Ahvaz Jundishapur University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02579902
Brief Title
Effect of Vitamin D3 Supplementation in Treatment of Irritable Bowel Syndrome
Official Title
Effect of Vitamin D3 Supplementation on Clinical Signs, Oxidative Stress and Inflammatory Biomarkers in Patients With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahvaz Jundishapur University of Medical Sciences

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether vitamin D3 supplementation is effective in the treatment of clinical signs, biomarkers of inflammation and oxidative stress due to Irritable Bowel Syndrome (IBS).
Detailed Description
This randomized double blind clinical trial will be performed on 90 patients (45 in intervention and 45 in control group) diagnosed with IBS. The intervention group will receive 50000 IU vitamin D3 and the control group will receive placebo contains edible paraffin once every 2 weeks for six months. Variables including biomarkers of inflammation and oxidative stress, serum levels of calcium and vitamin D, anthropometric indicators and blood pressure will be measured at baseline and end of the study. The investigators will use Rome III questionnaire for evaluating the clinical signs of the disease. The questionnaires will be filled out at baseline and every 2 weeks by the patients for six months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, inflammation, oxidative stress, clinical signs, vitamin D3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3
Arm Type
Active Comparator
Arm Description
50000 IU vitamin D3 capsule, one capsule every 2 weeks for 6 months.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule, one capsule every 2 weeks for 6 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3 (Cholecalciferol)
Intervention Description
50000 IU Vitamin D3 (Cholecalciferol) will be given as one gelcaps every 2 weeks for a period of 6 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
placebo will be given in identical gelcaps once every 2 weeks for a period of 6 months.
Primary Outcome Measure Information:
Title
Clinical signs including abdominal pain, bloating, rumbling, abdominal distention, dissatisfaction with stool consistency
Description
clinical signs will be assessed by Visual Analog Scale (VAS) 0-100mm self-report questionnaire at baseline and every two weeks for six months.
Time Frame
up to six months
Title
Symptom Severity Score
Description
symptom severity score will be assessed by IBS-Symptom Severity Score (IBS-SSS) self-report questionnaire baseline and after six months intervention.
Time Frame
up to six months
Secondary Outcome Measure Information:
Title
Dietary intake
Description
24-Hour dietary recalls questionnaires will be used to assess dietary pattern at baseline and after 3 and 6 months intervention.
Time Frame
up to six months
Title
Body Weight
Description
Body Weight will be measured in kilograms at baseline and after six months intervention.
Time Frame
up to six months
Title
Body Mass Index (BMI)
Description
BMI is weight in kilograms divided to height in meters squared. It will be measured at baseline and after six months intervention.
Time Frame
up to six months
Title
Waist Circumference (WC)
Description
WC will be measured in centimeter at baseline and after six months intervention.
Time Frame
up to six months
Title
Hip Circumference (HC)
Description
HC will be measured in centimeter at baseline and after six months intervention.
Time Frame
up to six months
Title
Waist to Hip Ratio (WHR)
Description
WHR is WC divided to HC. It will be measured at baseline and after six months intervention.
Time Frame
up to six months
Title
Blood Pressure (BP)
Description
BP will be measured in mmHg at baseline and after six months intervention.
Time Frame
up to six months
Title
Health-related Quality of Life
Description
Health-Related Quality of Life will be assessed by IBS-Quality Of Life (IBS-QOL) with 34-item Short-Form (SF-34) self-report questionnaire at baseline and after six months intervention.
Time Frame
up to six months
Title
Tumor Necrosis Factor-α (TNF-α)
Description
Blood serum TNF-α will be assessed by enzyme-linked immunosorbent assay (ELISA) at baseline and after six months intervention.
Time Frame
up to six months
Title
Interleukin-10 (IL-10)
Description
Blood serum IL-10 will be assessed by ELISA at baseline and after six months intervention.
Time Frame
up to six months
Title
Interleukin-17 (IL-17)
Description
Blood serum IL-17 will be assessed by ELISA at baseline and after six months intervention.
Time Frame
up to six months
Title
Malondialdehyde (MDA)
Description
Blood serum MDA will be assessed by Thiobarbituric acid (TBA) method at baseline and after six months intervention.
Time Frame
up to six months
Title
Total Antioxidant Capacity (TAC)
Description
Blood serum TAC will be assessed by Ferric Reducing Antioxidant Power (FRAP) assay at baseline and after six months intervention.
Time Frame
up to six months
Title
25-hydroxy vitamin D (25(OH)D)
Description
Blood serum 25(OH)D will be assessed by Radioimmunoassay at baseline and after six months intervention.
Time Frame
up to six months
Title
Calcium
Description
Blood serum Calcium will be assessed by Arsenazo III method at baseline and after six months intervention
Time Frame
up to six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients who are diagnosed with Irritable Bowel Syndrome (IBS) according to ROME III criteria; Signed consent by the patient. Exclusion Criteria: Patients who have celiac disease (diagnosed by a duodenal biopsy or celiac serological tests) Any other diseases of the gastrointestinal tract such as Inflammatory Bowel Disease (IBD) Any kind of abdominal surgery Chronic disease such as diabetes Cardiovascular, hepatic Kidney and severe infection Pregnancy Breastfeeding Smoking Alcohol consumption Use of dietary supplements Use of vitamin D and calcium supplement during the last year before the study Use any medication for signs improvement during the study period.
Facility Information:
Facility Name
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
State/Province
Khuzestan
ZIP/Postal Code
15794 - 61357
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Effect of Vitamin D3 Supplementation in Treatment of Irritable Bowel Syndrome

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