Vitamin D in Pediatric Crohn's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 4
- 主要终点
- The proportion of pediatric CD patients achieving optimal 25OHD concentration
研究概览
简要总结
Background: Crohn's disease (CD), a type of Inflammatory Bowel Disease (IBD), is a chronic relapsing inflammatory disorder of the digestive system. CD affects ~112,000 individuals in Canada, of whom 20-25% are diagnosed in childhood or adolescence. The specific cause of CD remains unknown; however, it is hypothesized that CD involves a complex interaction of several factors, including a genetically susceptible host, the intestinal mucosal immune system and microbe population. Several dietary factors have been explored for their potential role in the etiology of CD. However, no consensus on the role of diet has emerged. Recent evidence suggests a plausible link between a lack of Vitamin D and CD.
Purpose & Hypothesis: The investigators primary hypothesis is that a greater proportion of pediatric CD patients will achieve optimal 25OHD concentration (> 75 nmol/L) on 2000 IU/d than 400 IU/d Vitamin D.
Methods: Pediatric Crohn's Disease patients between 8-18 years of age, and have been in remission for at least 4 weeks as indicated by a Pediatric Crohn's Disease Activity Index (PCDAI) <10 will be recruited for a double-blind, randomized, controlled trial where they will receive one of two dosages of vitamin D (10 or 50 ug/day) and will be asked to continue the supplementation for 6 months. Vitamin D levels will be measured in blood at baseline, 3 months, and 6 months. Dietary vitamin D intake will be estimated using a food frequency and lifestyle questionnaire. Data will be analyzed using multiple regression analysis controlling for baseline values.
Expected Results and Conclusions: It is expected that a greater proportion of children receiving the 50 ug/day vitamin D supplement will achieve a blood vitamin level >75 nmol/L compared to children receiving 10 ug/day. This data will aid policy makers, parents/children and healthcare workers in recommending an appropriate vitamin D dosage for the pediatric crohn's population.
详细描述
Trial Objectives: Our primary hypothesis is that a greater proportion of pediatric CD patients will achieve optimal 25OHD concentration (> 75 nmol/L) on 2000 IU/d than 400 IU/d Vitamin D. Our primary objective is to determine whether the proportion of pediatric CD patients achieving 25OHD concentration > 75 nmol/L is greater in those receiving 2000 IU/d or 400 IU/d Vitamin D. Our secondary objective is to determine if patients receiving 2000 IU Vitamin D are more likely to have remained in remission [Pediatric Crohn's Disease Activity Index (PCDAI) < 20] than those receiving 400 IU/d.
Study Design: This will be a parallel study design with two levels of Vitamin D: 400 IU/d, and 2000 IU/d supplement of Vitamin D3.
Study Duration: 6 Months
Number of Sites (inside and outside of Canada):
- Children's and Women's Hospital of British Columbia
- McMaster's Children's Hospital
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be eligible to participate if they have a diagnosis of CD, are between 8-18 years of age, and have been in remission for at least 4 weeks as indicated by a PCDAI <10.
排除标准
- •Patients will be ineligible if they have active disease with a PCDAI > 10, taking corticosteroids, or taking more than 400 IU Vitamin D at enrollment.
结局指标
主要结局
The proportion of pediatric CD patients achieving optimal 25OHD concentration
时间窗: 6 months
To determine whether the proportion of pediatric CD patients achieving 25OHD concentration \> 75 nmol/L different between groups.
次要结局
- If patients receiving 2000 IU Vitamin D are more likely to have remained in remission(6 months)