VDORA1 Trial adverse event data in Vitamin D Oral Replacement in Asthma (VDORA1)

Vitamin D Oral Replacement in Asthma adverse event data
Study Description
The overall objective of the study was to determine the pharmacokinetics of Vitamin D supplementation in children who have asthma and are overweight or obese.

This study had two parts. In part 1, study participants were 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) was selected to use in part 2.

In part 2, study participants were randomized to the dose selected in part 1 or the 600 IU daily dose of vitamin D supplementation which were administered over a 16-week dosing period.

Across both parts, safety of each dose regimen of vitamin D supplementation was evaluated, and the effectiveness of each dose to achieve a serum level of 25(OH)D greater than or equal to 40 ng/ml was assessed. Children with obesity and asthma who meet the following criteria:
- Body mass index greater than or equal to 85% for age and sex
- Physician-diagnosed asthma
- Serum 25(OH) D level 10 ng/ml to less than 30 ng/ml at screening visit

哮喘患者维生素D口服替代治疗不良事件数据集

研究描述
本研究的总体目标为明确超重/肥胖哮喘儿童补充维生素D的药代动力学特征。

本研究分为两个阶段。第一阶段中，研究对象被随机分配至4种以国际单位（IU）标示剂量的维生素D补充方案之一，给药周期至少为16周：① 单次50000 IU负荷剂量+每日6000 IU剂量；② 单次50000 IU负荷剂量+每日10000 IU剂量；③ 每日6000 IU剂量；④ 每日600 IU剂量。基于药代动力学分析结果，从方案1~3中选定一种方案用于第二阶段研究。

第二阶段中，研究对象被随机分配至第一阶段选定的剂量组，或每日600 IU的维生素D补充剂量组，给药周期均为16周。

两个阶段均对各维生素D补充剂量方案的安全性进行了评估，并针对各剂量使受试者血清25-羟维生素D（25(OH)D）水平达到≥40 ng/ml的有效性进行了评价。

符合以下入组标准的超重/肥胖哮喘儿童：
- 年龄与性别匹配的身体质量指数（Body Mass Index, BMI）≥85百分位
- 经医师确诊的哮喘
- 筛查访视时血清25-羟维生素D（25(OH)D）水平处于10 ng/ml至<30 ng/ml区间