NCT01713231已完成4 期
Effect of High-Dose Vitamin D on Bone Density in Osteogenesis Imperfecta
Louis-Nicolas Veilleux Ph.D.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in areal bone mineral density z-score of the lumbar spine
研究概览
简要总结
- Overall Objective: To test the hypothesis that oral vitamin D supplementation at higher than currently prescribed doses has a beneficial effect on the skeleton of young patients with osteogenesis imperfecta (OI).
- Specific Aims: 1. To determine whether 12 months of high-dose vitamin D supplementation, compared to standard-dose vitamin D supplementation, increases areal bone mineral density z-scores at the lumbar spine. 2. To examine the effectiveness of high-dose vitamin D supplementation to increase trabecular and cortical bone mineral density at the radius. 3. To examine whether high-dose vitamin D supplementation has an effect on physiological determinants of bone mass (parathyroid hormone, activity of bone metabolism, muscle function).
- Background: In a preliminary cross-sectional study of 282 OI patients we observed an inverse relationship between serum 25-hydroxyvitamin D and parathyroid hormone levels and a positive relationship between circulating levels of 25-hydroxyvitamin D and lumbar spine areal bone mineral density z-scores. This suggested that high-dose vitamin D supplementation would have a beneficial effect on bone density. Most OI patients currently receive oral vitamin D supplementation of 400 International Units per day, but doses of 2000 International Units per day are safe and have been shown to be beneficial in studies on healthy adolescents.
- Study Design: This is a parallel-group double-blind randomized controlled trial of 12 months duration on 60 children and adolescents aged 6 to 19 years with a clinical diagnosis of OI. One group of 30 participants will be randomized to receive vitamin D3 at a dose of 2000 international units per day ('high-dose group'). The other group of 30 participants will be randomized to receive vitamin D3 at a dose of 400 international units per day ('standard-dose group'). Randomization will be stratified according to pubertal status and bisphosphonate treatment status.
- Clinical Relevance: The proposed study aims at direct improvements in the care of OI patients. If a simple and low-cost 'intervention' such as high-dose vitamin D supplementation can be shown to be effective in relieving some of the disease burden associated with OI, the benefit to OI patients worldwide would be substantial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of OI of any type.
排除标准
- •Any condition that renders bone density measurements at the lumbar spine impossible. An example for this is prior spinal fusion surgery.
- •Bisphosphonate therapy for less than two years duration.
- •Use of medication, other than bisphosphonates, known to affect bone metabolism or 25OHD serum concentrations. Examples are anti-epileptics, active vitamin D metabolites, corticosteroids and thyroid hormones.
- •Liver and renal disease known to interfere with vitamin D metabolism.
- •Any other disorder of calcium and phosphate metabolism (apart from vitamin D deficiency) that might interfere with PTH.
研究组 & 干预措施
standard-dose vitamin D
Active Comparator
one group of 30 participants will be randomized to receive vitamin D3 at a dose of 400 international units per day ('standard-dose group').
干预措施: standard-dose vitamin D (400IU per day) (Dietary Supplement)
high-dose vitamin D
Experimental
One group of 30 participants will be randomized to receive vitamin D3 at a dose of 2000 international units per day ('high-dose group').
干预措施: high-dose vitamin D (2000 IU per day) (Dietary Supplement)
结局指标
主要结局
Change in areal bone mineral density z-score of the lumbar spine
时间窗: at baseline and 12 months
LS-aBMD z-score will be used as the primary outcome.The lumbar spine is the standard site of measurement both in the clinical follow up of OI patients .
次要结局
- Change in trabecular and cortical volumetric bone mineral density z-scores at the radius, as measured by pQCT, relative to baseline.(at baseline and at 12 months)
研究者
Louis-Nicolas Veilleux Ph.D.
postdoctoral fellow
Shriners Hospitals for Children
研究点 (1)
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