Vitamin D Oral Replacement in Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 30
- 主要终点
- Part 1: Optimal Dosing Level to Use in Part 2
研究概览
简要总结
The overall objective of the study is to determine the pharmacokinetics of Vitamin D supplementation in children who have asthma and are overweight or obese.
详细描述
This study has two parts. In part 1, study participants will be randomized to receive one of four doses of vitamin D supplementation in international units (IU) over at 16-week period: 1) Single 50,000 IU loading dose + 6000 IU daily dose; 2) Single 50,000 IU loading dose + 10,000 IU daily dose: 3) 6000 IU daily dose; or 4) 600 IU daily dose. Based on pharmacokinetic analysis, one of the doses (1-3) will be selected to use in part 2.
In part 2, study participants will be randomized to the dose selected in part 1 or the 600 IU daily dose of vitamin D supplementation to be administered over a 16-week dosing period.
Across both parts, safety of each dose regimen of vitamin D supplementation will be evaluated, and the effectiveness of each dose to achieve a serum level of 25(OH)D greater than or equal to 40 ng/ml will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index greater than or equal to 85% for age and sex
- •Physician-diagnosed asthma
- •Ongoing relationship with asthma provider responsible for asthma care
- •Serum 25(OH) D level 10 ng/ml to less than 30 ng/ml at screening visit based on local laboratory test
- •Ability to swallow pills similar in size to the vitamin D preparation to be used
- •Signed consent form from parent, legal guardian or caregiver and signed assent from participant (as appropriate)
- •Females of childbearing years must not be pregnant, must not be lactating and must agree to practice adequate birth control method
- •Child and parent, legal guardian, or caregiver must speak English or Spanish
排除标准
- •Known diseases of calcium metabolism or the parathyroid
- •History of renal insufficiency or kidney stones
- •Known liver failure or history of abnormal liver function tests
- •History of Williams syndrome, sarcoidosis, or granulomatous disease
- •Active tuberculosis
- •Spot urine calcium/creatinine ration greater than 0.37 (calcium and creatinine measured in mg/ml). This can be repeated following adequate hydration
- •Clinical evidence of rickets
- •Taking supplemental vitamin D greater than equal to 1000 IU per day
结局指标
主要结局
Part 1: Optimal Dosing Level to Use in Part 2
时间窗: 20 weeks
Determine the best vitamin D supplementation level based on PK analysis of participants enrolled in Part 1. The PK of 25(OH)D after vitamin D supplementation in children will be characterized using a 2-compartment population PK model (popPK) with linear absorption and elimination kinetics.
Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml
时间窗: 16 weeks
Proportion of participants in part 2 who achieve vitamin levels \>= 40 ng/ml
次要结局
未报告次要终点