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临床试验/NCT00957879
NCT00957879已完成不适用

Effect of Different Vitamin D Preparations on Circulating FGF23 Levels in Vitamin D Deficient Caucasian and African-American Men and Women

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2009年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Change in FGF23 levels

研究概览

简要总结

Fibroblast growth factor 23 (FGF23) is a new hormone which controls phosphate and vitamin D levels in humans. Excess FGF23 is associated with an increased risk of death in patients with chronic kidney disease. In this study the investigators are investigating the effects of different forms of vitamin D on FGF23 levels in the blood in order to increase our understanding of how this important hormone works.

详细描述

Fibroblast growth factor 23 (FGF23) is a novel hormone involved in phosphate and vitamin D physiology. X-linked hypophosphatemia (XLH), autosomal dominant hypophosphatemic rickets (ADHR), and tumor induced osteomalacia (TIO) are 3 rare diseases characterized by rickets/osteomalacia, fractures, and hypophosphatemia secondary to renal phosphate wasting and inappropriately low levels of activated vitamin D (calcitriol), which are caused by excess amounts of or mutated FGF23. FGF23 excess also occurs in renal failure, where elevated FGF23 levels predict increased mortality. Thus, abnormal FGF23 appears to be central to both rare and common diseases. While FGF23 appears to be regulated by vitamin D, dietary and serum phosphate, much is still unknown. The effects of different forms of vitamin D on FGF23 stimulation are not well characterized. Similarly, any racial differences in the regulation of FGF23 by vitamin D have not been investigated.

To address these knowledge deficits, we will randomize 52 vitamin D deficient (25OHD < or = 24 ng/mL by LC/MS) Caucasian and African-American men and women to treatment with either dietary vitamin D or activated vitamin D for 12 weeks. Our primary endpoint will be the change in FGF23 with dietary versus activated vitamin D.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 45 yrs
  • Serum 25OHD < 24 ng/mL by liquid chromatography/mass spectroscopy
  • At least 1 menses in the last 3 months (females) and normal serum testosterone (males)
  • African-American or Caucasian race

排除标准

  • Significant cardiac, hepatic, oncologic, or psychiatric disease
  • History of malabsorption, kidney stones, or recent alcohol excess/abuse
  • Use of medications known to affect serum phosphate levels including phosphate-binding antacids, sodium etidronate, calcitonin, excessive doses of vitamin D (> 1000 units per day), excessive doses of vitamin A (> 20,000 units/day), calcitriol, growth hormone, or anti-convulsants
  • Use of thiazide diuretics or cholestyramine
  • Serum calcium < 8 or > 11 mg/dL, creatinine > 1.5 mg/dL, or Hgb < 11 gm/dL
  • Serum glucose >140mg/dL
  • Liver function tests > 2 times the upper limit of normal
  • TSH < 0.1 or > 7 uU/mL
  • WBC < 2,000 or > 15,000/cmm
  • Platelet count < 100,000 or > 500,000/cum
  • Hormone replacement therapy (however, oral contraceptives are allowed) or testosterone use
  • Urine beta-hCG positive (females)
  • Serum phosphate > 4.6 mg/dL
  • Allergy to vitamin D

结局指标

主要结局

Change in FGF23 levels

时间窗: 12 weeks

次要结局

  • Change in serum phosphate(12 weeks)
  • Change in urinary phosphate(12 weeks)
  • Change in serum calcium(12 weeks)

研究者

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

Sherri-Ann M. Burnett-Bowie

Assistant Professor of Medicine

Massachusetts General Hospital

研究点 (2)

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