NCT05165173已完成不适用
Almond Milk With Vitamin D: Impact on Vitamin D Status
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Vitamin D
研究概览
简要总结
The overall goal is to enhance vitamin D status in a safe and effective manner. A 3-week randomized comparator-controlled trial among a cohort of adults with CKD (stages 3-5) (n=24) will test the main objective: Evaluate the bioefficacy of D3 in micro- and nanoparticles (4000IUs) in almond milk with the sub-objective of: Explore the effect of D3 in micro- and nanoparticles (4000IUs) in almond milk on inflammation markers CRP, TNF-α and IL-6.
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
- Double (Participant, Investigator)
盲法说明
Participants will receive a coded sample that either contains 4000 IUs microparticles of vitamin D or 4000 IUs nanoparticles of vitamin D
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults who have been diagnosed with CKD
- •have no GI disorders or GI disturbances
- •age 18 years or older
- •no food allergies or dietary restrictions
- •all with no contraindications to consuming anything by mouth as per their physician
排除标准
- •no diagnosis of CKD
- •GI disorders
- •gastrointestinal disturbances
- •under 18 years old
- •food allergies to almonds
- •Dietary restrictions as medically indicated
- •trouble chewing/swallowing as confirmed by physician
结局指标
主要结局
Vitamin D
时间窗: 21 days
baseline to end line in the concentration of serum 25(OH)D3 between and within the control and intervention groups.
次要结局
- Calcium(21 days)
- PTH(21 days)
- IL-6(21 days)
- TNF-alpha(21 days)
- parent vitamin D(21 days)
- C-reactive protein(21 days)
研究者
研究点 (2)
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