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临床试验/NCT02076750
NCT02076750已完成1 期

Weekly Vitamin D3 for Treatment of Hypovitaminosis D in Children and Adolescents With Inflammatory Bowel Disease

Emory University4 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
34
试验地点
4
主要终点
Change from baseline serum 25-OH vitamin D level at 8 and 12 weeks

研究概览

简要总结

The purpose of this study is to determine whether weekly dosing of oral vitamin D3 is effective in correcting low vitamin D levels in children and adolescents with inflammatory bowel disease (also known as Crohn's disease and ulcerative colitis).

详细描述

The role of vitamin D in skeletal health is well established. More recently, vitamin D has been implicated in multiple other disease states and is currently a topic of much discussion in the pediatric and adult medical literature. Individuals with gastrointestinal or hepatobiliary diseases that limit the absorption of dietary vitamin D and those individuals with limited sunlight exposure or darker skin color are at risk for suboptimal vitamin D status. Recent joint guidelines from the North American and European Societies of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN and ESPGHAN, respectively) have recommended routine surveillance and treatment for vitamin D insufficiency/deficiency in children affected by inflammatory bowel diseases (IBD), namely Crohn's disease (CD) and ulcerative colitis (UC). Current recommendations are for prolonged daily dosing of oral vitamin D, but studies in children with other chronic diseases have demonstrated the benefit of improved compliance with less frequent, higher doses of vitamin D. The primary goal of this pilot study is to establish whether weekly dosing of vitamin D can correct suboptimal vitamin D status in children with inflammatory bowel disease. A secondary goal is to evaluate whether pediatric IBD patients with darker skin respond differently to vitamin D therapy than do their lighter-skinned counterparts.

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
Single (Investigator)

入排标准

年龄范围
8 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Established diagnosis of inflammatory bowel disease made by a pediatric gastroenterologist and confirmed by histopathology
  • Serum 25-OH vitamin D level <30 ng/mL at time of enrollment.
  • Age 8-21 years
  • Weight > 20 kg
  • Parent, guardian, or subject (where applicable) able to give consent/assent

排除标准

  • Inability to ingest oral vitamin D3 capsules
  • Presence of known hepatobiliary disease
  • Presence of known kidney disease or history of renal stones
  • Use of systemic steroids within 60 days prior to enrollment.

结局指标

主要结局

Change from baseline serum 25-OH vitamin D level at 8 and 12 weeks

时间窗: Weeks 0, 8 and 12 of study.

次要结局

  • Change from baseline serum calcium level at 8 and 12 weeks(Weeks 0, 8 and 12 of study.)
  • Change from baseline serum parathyroid hormone level at 8 and 12 weeks(Weeks 0, 8 and 12 of study)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Subra Kugathasan, MD

Professor

Emory University

研究点 (4)

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