Vitamin D Deficiency in Adolescent Girls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- change in FGF23 level with vitamin D repletion
研究概览
简要总结
Fibroblast growth factor 23 (FGF23) is a newly discovered hormone which regulates phosphate and vitamin D levels. In this study, we are looking at what the normal levels of FGF23 are in adolescent girls and how these levels vary with other hormonal measurements. We will also be looking at whether vitamin D supplementation in adolescents who are deficient in vitamin D alters the levels of FGF23 and other factors including insulin resistance.
详细描述
Fibroblast growth factor 23 (FGF23) is a newly discovered hormone. Its primary function is to regulate phosphate metabolism, which it does both by directly regulating phosphate excretion through the kidney as well as by regulating vitamin D activity. What controls FGF23 levels is still under investigation; potential factors include dietary phosphate intake and vitamin D levels.
In this pilot study, we aim to investigate what the normal levels of FGF23 are in healthy girls and how these are related to other measurements of bone and mineral metabolism. Since vitamin D deficiency is very common in healthy girls, we expect a subset of the subjects in this study to be vitamin D deficient. We will then randomize these girls to vitamin D repletion or placebo and follow changes in FGF23 levels. Vitamin D deficiency has also been implicated in insulin resistance which is a precursor to diabetes. We will therefore also look at changes in insulin resistance with vitamin D repletion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy girls aged 9-18 years
排除标准
- •significant cardiac, hepatic, oncologic, or psychiatric disease
- •a history of malabsorption, kidney stones, hypoparathyroidism, or growth hormone deficiency
- •pregnancy
- •diabetes mellitus
- •BMI>/= 99th percentile for age and sex
- •fracture within the preceding 3 months
- •hypogonadism (no pubertal development by age 12, absence of menarche by age 14)
- •serum calcium <8 mg/dl or >11 mg/dl
- •radiographic evidence of rickets
- •use of medications know 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 D (>20,000 units/day), calcitriol, growth hormone, or anti-convulsants.
- •use of hormonal birth control
结局指标
主要结局
change in FGF23 level with vitamin D repletion
时间窗: baseline and 16 weeks
次要结局
- change in bone turnover markers with vitamin D repletion(baseline and 16 weeks)
- change in mineral metabolism factors with vitamin D repletion(baseline and 16 weeks)
- change in insulin sensitivity with vitamin D repletion(baseline and 16 weeks)
研究者
Sherri-Ann M. Burnett-Bowie
Assistant Professor of Medicine
Massachusetts General Hospital