Comparison of Changes in Serum 25(OH)D Concentrations Following Vitamin D Supplementation With Chewable Tablets Versus Pills
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in Serum 25(OH)D concentration
研究概览
简要总结
This is a 6-month cross-over trial of vitamin D supplementation in 38 healthy men and women aged 18 years and older. The primary aim is to compare the change in serum 25(OH)D concentration following vitamin D supplementation with chewable tablets versus pills. Secondary aims are to evaluate satisfaction and adherence to the vitamin D chewable tablet supplement. Questionnaires on physical activity, sunlight exposure and dairy product consumption will be administered to adjust for confounding factors. A questionnaire will be administered to assess satisfaction and pill count to evaluate adherence to treatment. This research intends to test the hypothesis that the vitamin D chewable tablet supplement is as effective as a traditional vitamin D pill supplement to increase serum 25(OH)D concentrations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian men and women;
- •Aged 18 years and older;
- •Having a serum 25(OH)D concentration of 75 nmol/L or less.
排除标准
- •Regular consumption of a supplement containing > 400 IU/d of vitamin D over the last 2 months;
- •Intestinal malabsorption;
- •Cirrhosis;
- •Renal insufficiency (creatinine clearance <60 ml/min);
- •Hypercalcemia;
- •Pregnancy;
- •Breastfeeding;
- •Inability to provide informed consent.
研究组 & 干预措施
Vitamin D chewable tablet supplementation
A chewable vitamin D tablet containing 1000 IU to be taken once a day for 2 months.
干预措施: Vitamin D chewable tablet supplementation (Drug)
Vitamin D pill supplementation
A vitamin D pill containing 1000 IU to be taken once a day for 2 months.
干预措施: Vitamin D pill supplementation (Drug)
结局指标
主要结局
Change in Serum 25(OH)D concentration
时间窗: 0 and 2 months, 4 and 6 months
次要结局
- Satisfaction with the vitamin D chewable tablets and pills.(0 and 2 months, 4 and 6 months)
- Adherence to the vitamin D chewable tablets and pills.(0 and 2 months, 4 and 6 months)
研究者
Claudia Gagnon
MD
CHU de Quebec-Universite Laval