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Effect of Vitamin D3 Supplementation in Treatment of Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02579902
Recruitment Status : Completed
First Posted : October 20, 2015
Last Update Posted : November 30, 2015
Sponsor:
Information provided by (Responsible Party):
Amir Abbasnezhad, Ahvaz Jundishapur University of Medical Sciences

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).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: Vitamin D3 (Cholecalciferol) Dietary Supplement: placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D3 Supplementation on Clinical Signs, Oxidative Stress and Inflammatory Biomarkers in Patients With Irritable Bowel Syndrome
Study Start Date : February 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Active Comparator: Vitamin D3
50000 IU vitamin D3 capsule, one capsule every 2 weeks for 6 months.
Dietary Supplement: Vitamin D3 (Cholecalciferol)
50000 IU Vitamin D3 (Cholecalciferol) will be given as one gelcaps every 2 weeks for a period of 6 months.

Placebo Comparator: placebo
Placebo capsule, one capsule every 2 weeks for 6 months.
Dietary Supplement: placebo
placebo will be given in identical gelcaps once every 2 weeks for a period of 6 months.




Primary Outcome Measures :
  1. Clinical signs including abdominal pain, bloating, rumbling, abdominal distention, dissatisfaction with stool consistency [ Time Frame: up to six months ]
    clinical signs will be assessed by Visual Analog Scale (VAS) 0-100mm self-report questionnaire at baseline and every two weeks for six months.

  2. Symptom Severity Score [ Time Frame: up to six months ]
    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 :
  1. Dietary intake [ Time Frame: up to six months ]
    24-Hour dietary recalls questionnaires will be used to assess dietary pattern at baseline and after 3 and 6 months intervention.

  2. Body Weight [ Time Frame: up to six months ]
    Body Weight will be measured in kilograms at baseline and after six months intervention.

  3. Body Mass Index (BMI) [ Time Frame: up to six months ]
    BMI is weight in kilograms divided to height in meters squared. It will be measured at baseline and after six months intervention.

  4. Waist Circumference (WC) [ Time Frame: up to six months ]
    WC will be measured in centimeter at baseline and after six months intervention.

  5. Hip Circumference (HC) [ Time Frame: up to six months ]
    HC will be measured in centimeter at baseline and after six months intervention.

  6. Waist to Hip Ratio (WHR) [ Time Frame: up to six months ]
    WHR is WC divided to HC. It will be measured at baseline and after six months intervention.

  7. Blood Pressure (BP) [ Time Frame: up to six months ]
    BP will be measured in mmHg at baseline and after six months intervention.

  8. Health-related Quality of Life [ Time Frame: up to six months ]
    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.

  9. Tumor Necrosis Factor-α (TNF-α) [ Time Frame: up to six months ]
    Blood serum TNF-α will be assessed by enzyme-linked immunosorbent assay (ELISA) at baseline and after six months intervention.

  10. Interleukin-10 (IL-10) [ Time Frame: up to six months ]
    Blood serum IL-10 will be assessed by ELISA at baseline and after six months intervention.

  11. Interleukin-17 (IL-17) [ Time Frame: up to six months ]
    Blood serum IL-17 will be assessed by ELISA at baseline and after six months intervention.

  12. Malondialdehyde (MDA) [ Time Frame: up to six months ]
    Blood serum MDA will be assessed by Thiobarbituric acid (TBA) method at baseline and after six months intervention.

  13. Total Antioxidant Capacity (TAC) [ Time Frame: up to six months ]
    Blood serum TAC will be assessed by Ferric Reducing Antioxidant Power (FRAP) assay at baseline and after six months intervention.

  14. 25-hydroxy vitamin D (25(OH)D) [ Time Frame: up to six months ]
    Blood serum 25(OH)D will be assessed by Radioimmunoassay at baseline and after six months intervention.

  15. Calcium [ Time Frame: up to six months ]
    Blood serum Calcium will be assessed by Arsenazo III method at baseline and after six months intervention



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579902


Locations
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Iran, Islamic Republic of
Ahvaz Jundishapur University of Medical Sciences
Ahvaz, Khuzestan, Iran, Islamic Republic of, 15794 - 61357
Sponsors and Collaborators
Ahvaz Jundishapur University of Medical Sciences
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Responsible Party: Amir Abbasnezhad, Ph.D candidate of Nutrition Sciences, Ahvaz Jundishapur University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02579902    
Other Study ID Numbers: ir.ajums.rec.1394.306
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2015
Keywords provided by Amir Abbasnezhad, Ahvaz Jundishapur University of Medical Sciences:
Irritable Bowel Syndrome
inflammation
oxidative stress
clinical signs
vitamin D3
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents