一个比较和安全性评估的小与标准维生素D3口服补充在一个随机,双盲的人类试点研究
Julia Solnier1, Chuck Chang1, Yiming Zhang1
1ISURA, Clinical Research, Burnaby, BC V3N4S9, Canada.
Nutrients
|June 19, 2024
概括
微粒维生素D3 (LMD) 在1000 IU剂量时显示出明显高于标准维生素D3的生物可用性. 这两种配方都是安全的,LMD在健康成年人中显示了增强的吸收.
科学领域:
- 内分泌学 在内分泌学.
- 营养科学 营养科学
- 药理动力学 药理动力学
背景情况:
- 维生素D3对于骨健康和免疫功能至关重要.
- 维生素D3补充剂的生物可用性可能因配方而异.
- 细胞输送系统的目的是改善营养吸收.
研究的目的:
- 为了比较标准维生素D3的生物可用性和安全性与微粒维生素D3配方.
- 在60天的时间内评估两种不同的每日剂量 (1000 IU和2500 IU).
- 评估维生素D3配方的药理动力学特征和安全标记.
主要方法:
- 这是一项双盲,随机四臂并行研究,涉及35名健康成年人.
- 参与者每天接受1000 IU或2500 IU的标准或小粒维生素D3.
- 在多个时间点测量血清二醇[25(OH) D]水平;在基线和研究结束时评估安全标记.
主要成果:
- 与标准维生素D3 (STD1000) 相比,微粒维生素D3 (LMD1000) 在1000 IU剂量时显示出显著更高的生物可用性 (高达6倍).
- 在随访期间,LMD1000组维护的维生素D3度大约是STD1000组的7倍.
- 在2500 IU剂量的标准配方和小粒配方之间没有观察到显著的药理动力学差异;两者都是安全的,没有不良事件.
结论:
- 微粒维生素D3 (LipoMicel®) 与标准维生素D3相比,在健康成年人中,在1000 IU剂量下提供更好的生物可用性.
- 细胞配方是安全的,不会增加高血症或其他不良事件的风险.
- 进一步的研究可能会探索小粒维生素D3在较高剂量或在吸收不良问题的人群中的有效性.
关键词:
生物可用性 生物可用性胆结石醇是一种高酸.系统交付系统的交付系统.迈塞尔斯 (Micelles) 是一个很好的球员.药物动力学 药物动力学补充补充补充补充补充维生素D是维生素D的重要组成部分.更多相关视频
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