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临床试验/NCT00949832
NCT00949832已完成4 期

Vitamin D and Genetics in Nutritional Rickets

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2004年1月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
Mayo Clinic
入组人数
109
试验地点
2
主要终点
XR healing of rickets

研究概览

简要总结

The purpose of this study is:

  1. To compare the response of rickets to calcium with and without vitamin D.
  2. To assess whether vitamin D increases calcium absorption in calcium deficiency rickets.
  3. To compare the response of children with and without rickets to orally administered vitamin D3 and vitamin D2
  4. To identify mutations that influence calcium and vitamin D metabolism among families of children with rickets in Nigeria and Bangladesh.
  5. To assess the functional status of the 25-hydroxylase enzyme in families possessing a 25-hydroxylase mutation.

详细描述

Previous studies of Nigerian children with rickets demonstrated the superiority of calcium over vitamin D in producing healing. It is not known whether the addition of vitamin D to calcium will produce a better response to treatment than calcium alone in Nigerian children. A previous study suggested the possibility that vitamin D may augment the effect of calcium. We will compare the response of rickets to calcium with and without vitamin D. In addition, very little human data clearly demonstrates the effect of supplemental vitamin D on calcium absorption. We will assess whether oral vitamin D increases the already high calcium absorption even further.

Recent published data indicate that the increase in serum 25-hydroxyvitamin D may be more sustained with vitamin D3 than with vitamin D2. We will compare the response of Nigerian children with and without rickets to orally administered vitamin D3 and vitamin D2.

Because nutritional rickets tends to run in families, we will also examine amplified DNA for evidence of mutations that influence calcium and vitamin D metabolism among families of children with rickets in Nigeria and Bangladesh. Families possessing a recently identified 25-hydroxylase mutation will be given oral vitamin D2 and vitamin D3 to determine the functional status of the 25-hydroxylase enzyme.

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 (Participant)

入排标准

年龄范围
6 Months 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical features of rickets
  • Active rickets on X-ray

排除标准

  • Treatment with calcium or vitamin D in preceding 30 days

结局指标

主要结局

XR healing of rickets

时间窗: 6 months

次要结局

  • 1,25-dihydroxyvitamin D(2 weeks)
  • Calcium absorption(1 week)
  • Alkaline phosphatase(6 months)
  • Serum calcium(6 months)
  • 25-hydroxyvitamin D(6 months)

研究者

发起方
Mayo Clinic
申办方类型
Other

研究点 (2)

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Vitamin D and Genetics in Nutritional Rickets | 临床试验