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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 | Active Comparator | 50000 IU vitamin D3 capsule, one capsule every 2 weeks for 6 months. |
|
| placebo | Placebo Comparator | Placebo capsule, one capsule every 2 weeks for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 (Cholecalciferol) | Dietary Supplement | 50000 IU Vitamin D3 (Cholecalciferol) will be given as one gelcaps every 2 weeks for a period of 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 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. | up to six months |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary intake | 24-Hour dietary recalls questionnaires will be used to assess dietary pattern at baseline and after 3 and 6 months intervention. | up to six months |
| Body Weight | Body Weight will be measured in kilograms at baseline and after six months intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahvaz Jundishapur University of Medical Sciences | Ahvāz | Khuzestan | 15794 - 61357 | Iran |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D007249 | Inflammation |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| placebo | Dietary Supplement | placebo will be given in identical gelcaps once every 2 weeks for a period of 6 months. |
|
| up to six months |
| 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. | up to six months |
| Waist Circumference (WC) | WC will be measured in centimeter at baseline and after six months intervention. | up to six months |
| Hip Circumference (HC) | HC will be measured in centimeter at baseline and after six months intervention. | up to six months |
| Waist to Hip Ratio (WHR) | WHR is WC divided to HC. It will be measured at baseline and after six months intervention. | up to six months |
| Blood Pressure (BP) | BP will be measured in mmHg at baseline and after six months intervention. | up to six months |
| 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. | up to six months |
| 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. | up to six months |
| Interleukin-10 (IL-10) | Blood serum IL-10 will be assessed by ELISA at baseline and after six months intervention. | up to six months |
| Interleukin-17 (IL-17) | Blood serum IL-17 will be assessed by ELISA at baseline and after six months intervention. | up to six months |
| Malondialdehyde (MDA) | Blood serum MDA will be assessed by Thiobarbituric acid (TBA) method at baseline and after six months intervention. | up to six months |
| Total Antioxidant Capacity (TAC) | Blood serum TAC will be assessed by Ferric Reducing Antioxidant Power (FRAP) assay at baseline and after six months intervention. | up to six months |
| 25-hydroxy vitamin D (25(OH)D) | Blood serum 25(OH)D will be assessed by Radioimmunoassay at baseline and after six months intervention. | up to six months |
| Calcium | Blood serum Calcium will be assessed by Arsenazo III method at baseline and after six months intervention | up to six months |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |