Ahvaz Jundishapur University of Medical Sciences
Ahvāz, Khuzestan, 15794 - 61357, Iran
NCT Number: NCT02579902
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).
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Notify Me18 year–70 year
All sexes
Interventional
Phase 1
Ahvāz, Khuzestan, 15794 - 61357, Iran
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
50000 IU Vitamin D3 (Cholecalciferol) will be given as one gelcaps every 2 weeks for a period of 6 months.
placebo will be given in identical gelcaps once every 2 weeks for a period of 6 months.
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.
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.
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.
Time frame: up to six months
Body Weight will be measured in kilograms at baseline and after six months intervention.
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.
Time frame: up to six months
WC will be measured in centimeter at baseline and after six months intervention.
Time frame: up to six months
HC will be measured in centimeter at baseline and after six months intervention.
Time frame: up to six months
WHR is WC divided to HC. It will be measured at baseline and after six months intervention.
Time frame: up to six months
BP will be measured in mmHg at baseline and after six months intervention.
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.
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.
Time frame: up to six months
Blood serum IL-10 will be assessed by ELISA at baseline and after six months intervention.
Time frame: up to six months
Blood serum IL-17 will be assessed by ELISA at baseline and after six months intervention.
Time frame: up to six months
Blood serum MDA will be assessed by Thiobarbituric acid (TBA) method at baseline and after six months intervention.
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.
Time frame: up to six months
Blood serum 25(OH)D will be assessed by Radioimmunoassay at baseline and after six months intervention.
Time frame: up to six months
Blood serum Calcium will be assessed by Arsenazo III method at baseline and after six months intervention
Ahvaz Jundishapur University of Medical Sciences
Other
Effect of Vitamin D3 Supplementation on Clinical Signs, Oxidative Stress and Inflammatory Biomarkers in Patients With Irritable Bowel Syndrome
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