The Impact of Serum Vitamin D and Calcium Levels on the Body Composition, Bone Mineral Density, Muscle Strength, Exercise Tolerance, Fatigue and Inflammatory Activity in Patients With Crohn's Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Increase in the grip strength in patients with Crohn under vitamin D supplementation
研究概览
简要总结
Thus, the aim of the current study is to assess the influence of vitamin D deficiency and, consequently, of serum calcium deficiency in the body composition, muscular activity, bone mineral density, fatigue, and exercise tolerance of CD patients. Secondly, it also aims to determine the impact of vitamin D supplementation on this population.
详细描述
This will be a clinical, randomized, controlled, and double-blind trial comprising a consecutive sample of 110 CD patients in remission and low serum vitamin D levels treated by the Gastroenterology team of the Inflammatory Intestinal Disease Clinic at the University Hospital (HU/CAS), Federal University of Juiz de Fora (UFJF). These patients will be divided into two groups with 55 patients each. One group will receive vitamin D supplementation (50.000 UI/week) and the other will receive placebo. Upon the approval by the Ethics Committee of the UFJF, the study aims and procedures will be previously explained to the individuals, who will sign an informed consent form.
The sample size was based on the handgrip strength test, assuming an alpha risk of 5 % and beta risk of 80 %, standard deviation of 2.5, and a difference in magnitude of 30% of response between intervention and placebo group, the sample size needed was 45 patients in each group. Therefore, considering potential losses, 55 patients will be recruited for each group, requiring a total of 110 volunteers.
Study procedure
Phase 1. Assessment All patients in the study will be subjected to the following tests: a. clinical assessment; B. biochemical assessment; c. body composition assessment/anthropometry; d. bone mineral density assessment; e. peripheral muscle strength assessment; f. fatigue assessment; g.Exercise Tolerance Testing
Clinical Assessment of the Disease The following data will be collected in the initial assessment: age, gender, CD duration, data related to the Montreal Classification (age at the time of diagnosis, disease behavior and location), glucocorticoid use and number of exacerbations in the previous year. The inflammatory activity assessment will be held according to the Harvey-Bradshaw Index, When the score is less than 5, the disease is considered to be inactive.
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)
盲法说明
Only the pharmacist responsible for confection of the tablets will know who will receive vitamin d or placebo, according to a list of randimization generated in the computer by the statistician. The list will be kept with the pharmacist throughout the intervention.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Crohn's Disease (moderate to severe)
- •Remission of Crohn's activity
- •Reduced blood levels of vitamin D
排除标准
- •Presence of other chronic concomitant disease
- •Presence of other autoimmune disease
- •Presence of sleep disturbance
- •Abuse of alcohol and other drugs
- •Pregnancy or lactation, climacteric and/or menopausal women
- •Adherence to extreme diet (e.g. macrobiotic or vegetarian diet)
- •Celiac disease
- •Presence of extensive resection of the small intestine (more than 100cm²)
- •Patients undergoing vitamin D replacement for the last 6 months.
研究组 & 干预措施
Placebo
The patients selected to the placebo group will receive inert content tablets without therapeutic effect, weekly, for six months.
干预措施: Placebo (Other)
Vitamin D
Tablets with 50000UI cholecalciferol (vitamin D3) will be administered, weekly, for six months.
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Increase in the grip strength in patients with Crohn under vitamin D supplementation
时间窗: After 6 months of supplementation with vitamin D
Grip strength will be expressed in kg
次要结局
- Increase in mineral bone density (MBD)(After 6 months of supplementation with vitamin D)
- Decrease in fecal Calprotectin levels(After 6 months of supplementation with vitamin D)
- Global reduction in laboratorial inflammatory biomarkers (TNF-α)(After 6 months of supplementation with vitamin D)
- Increase in exercise capacity assessed by Shuttle Walk Test (SWT)(After 6 months of supplementation with vitamin D)
- Increase in lean body mass in patients with Crohn under vitamin D supplementation(After 6 months of supplementation with vitamin D)
- Reduction in fatigue perception in patients with Crohn under vitamin D supplementation(After 6 months of supplementation with vitamin D)
- Global reduction in laboratorial inflammatory biomarkers (IL 6)(After 6 months of supplementation with vitamin D)
- Global reduction in laboratorial inflammatory biomarkers (IL 17)(After 6 months of supplementation with vitamin D)
- Global reduction in laboratorial inflammatory biomarkers (CRP)(After 6 months of supplementation with vitamin D)
研究者
Lorena Nagme de Oliveira Pinto
lecturer
Federal University of Juiz de Fora