Dexamethasone Treatment of Congenital Adrenal Hyperplasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Percent Difference in the Mean Log Transformed Area Under the Curve of 17-hydroxyprogesterone Between Regimens
研究概览
简要总结
The purpose of this study is to determine if dexamethasone given at night is a more effective treatment for congenital adrenal hyperplasia in young children than standard three times per day hydrocortisone. Our hypothesis is that nocturnal dexamethasone will lead to more efficient suppression of the hypothalamic-pituitary-adrenal axis. We performed a cross-over trial comparing hormonal control during two 24-hour hospitalizations, one on hydrocortisone and one on nocturnal dexamethasone.
详细描述
This is a Phase II clinical trial, intended to estimate the effect of instituting Dexamethasone therapy in comparison to prior standard therapy. Each subject provides his own baseline data. There is no control group. Patients with CAH who meet inclusion criteria will be admitted to the clinical research center for two 24 hour hospitalizations. Adrenal hormone profiles will be measured during each hospitalization. The patient will take his or her baseline hydrocortisone regimen during one hospitalization and a new regimen consisting of a single daily nocturnal dose of Dexamethasone during the second hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Classic salt-wasting 21-hydroxylase deficient congenital adrenal hyperplasia
- •Pre-pubertal children with bone ages below 8 years
排除标准
- •Age less than 2 years
- •Patients with additional medical conditions necessitating glucocorticoid therapy.
- •Patients on phenytoin, barbiturates, and rifampin as these medications accelerate the metabolism of glucocorticoids.
- •Patients on ketoconazole as this medication increases the bioavailability of glucocorticoids.
研究组 & 干预措施
Experimental
Experimental therapy with nocturnal dexamethasone.
干预措施: dexamethasone (Drug)
Experimental
Experimental therapy with nocturnal dexamethasone.
干预措施: Hydrocortisone (Drug)
结局指标
主要结局
Percent Difference in the Mean Log Transformed Area Under the Curve of 17-hydroxyprogesterone Between Regimens
时间窗: 23 hours
Each subject was admitted for 2 24 hour hospitalizations, one on hydrocortisone and one on dexamethasone. Due to the timing of blood draws, the serum hormonal profile was only measured for 23 hours. The primary outcome was the Percent Difference in the Mean log transformed Area under the curve of 17-hydroxyprogesterone between the two regimens.
次要结局
未报告次要终点