Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status: A 3 Month Placebo Controlled Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- The change in plasma concentrations of vitamin B12
研究概览
简要总结
A 3 months randomized, placebo-controlled study on the effect of toothpaste fortified with vitamin B12 on vitamin B12 status markers and related metabolic markers. The primary outcome variable is the difference in the change of methylmalonic acid after 3 months between the two study arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults: men and women
- •Stable diet for at least 24 months (omnivorous or a vegan diet).
排除标准
- •Pregnancy and lactation
- •Malabsorption disorders (Crohn disease, chronic gastritis, pernicious anemia, gastric or intestinal resection)
- •Renal diseases
- •Liver diseases
- •Patients with cancer (or cancer history)
- •Pre-study treatment with vitamin B12 or folate
研究组 & 干预措施
Placebo
A toothpaste, with the same matrix, all components, and appearance like the active arm but not containing vitamin B12.
干预措施: Placebo (Dietary Supplement)
Cyanocobalamin
A toothpaste with cyanocobalamin 100 µg cyanocobalamin per 1 g.
干预措施: Cyanocobalamin (Dietary Supplement)
结局指标
主要结局
The change in plasma concentrations of vitamin B12
时间窗: Baseline, 3 months
The effect on increasing plasma vitamin B12 in the B12 arm compared with the placebo arm
The change in plasma concentrations of methylmalonic acid
时间窗: Baseline, 3 months
Lowering methylmalonic acid in the B12 arm compared with the placebo arm
The change in plasma concentrations of holotranscobalamin
时间窗: Baseline, 3 months
The effect on increasing holotranscobalamin in the B12 arm compared with the placebo arm
The change in plasma concentrations of homocysteine
时间窗: Baseline, 3 months
Lowering homocysteine in the B12 arm compared with the placebo arm
次要结局
未报告次要终点
研究者
Rima Obeid
Prof. Dr.
Universität des Saarlandes