Effect of Vitamin D3 Supplementation on Clinical Signs, Oxidative Stress and Inflammatory Biomarkers in Patients With Irritable Bowel Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Clinical signs including abdominal pain, bloating, rumbling, abdominal distention, dissatisfaction with stool consistency
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients who are diagnosed with Irritable Bowel Syndrome (IBS) according to ROME III criteria; Signed consent by the patient.
排除标准
- •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
- •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.
研究组 & 干预措施
Vitamin D3
50000 IU vitamin D3 capsule, one capsule every 2 weeks for 6 months.
干预措施: Vitamin D3 (Cholecalciferol) (Dietary Supplement)
placebo
Placebo capsule, one capsule every 2 weeks for 6 months.
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
Clinical signs including abdominal pain, bloating, rumbling, abdominal distention, dissatisfaction with stool consistency
时间窗: 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.
Symptom Severity Score
时间窗: 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.
次要结局
- Body Weight(up to six months)
- Tumor Necrosis Factor-α (TNF-α)(up to six months)
- Interleukin-10 (IL-10)(up to six months)
- Interleukin-17 (IL-17)(up to six months)
- Total Antioxidant Capacity (TAC)(up to six months)
- Dietary intake(up to six months)
- Waist Circumference (WC)(up to six months)
- Waist to Hip Ratio (WHR)(up to six months)
- Blood Pressure (BP)(up to six months)
- Body Mass Index (BMI)(up to six months)
- Hip Circumference (HC)(up to six months)
- Health-related Quality of Life(up to six months)
- Malondialdehyde (MDA)(up to six months)
- Calcium(up to six months)
- 25-hydroxy vitamin D (25(OH)D)(up to six months)
研究者
Amir Abbasnezhad
Ph.D candidate of Nutrition Sciences
Ahvaz Jundishapur University of Medical Sciences