Vitamin D Intervention in Infants - Pilot
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- S-25OHD concentration after vitamin D supplementation to infants
研究概览
简要总结
The aims of the present study are to evaluate the concentrations of vitamin D in the plasma and of calcium in the plasma and in the urine as well as to evaluate bone mineral density using peripheral quantitative computed tomography (pQCT), after supplementation of vitamin D with 30µg (1200 IU) and 40µg (1600 IU), in comparison with currently recommended supplementation of vitamin D with 10µg (400 IU). In this pilot study supplementation is given to infants from 2 weeks of age to 3 months of age.
详细描述
Vitamin D deficiency is common around the world. In Finland vitamin D levels are low in all age groups. Especially infants are predisposed to vitamin D deficiency. Partly this is due to low exposure to sunlight but mainly it is due to low dietary intake of vitamin D. Vitamin D prophylaxis was introduced in Finland in the 1950´s to overcome rickets. However, the recommended dose has decreased from 50µg (2000 IU) in the 1960´s to 10µg (400 IU) from beginning of the 1990´s. The serum concentration of 25-hydroxyvitamin D (S-25OHD) is used as a marker of vitamin D status in the body. Although there is no consensus of optimal concentration of S-25OHD, it has been proposed that concentrations lower than 50 nmol/l indicate deficiency. According to recent findings on 25-OHD concentrations in Finnish children, currently recommended intake of vitamin D is inadequate.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy Caucasian women with an uneventful pregnancy
- •healthy infants born at term and appropriate for gestational age
排除标准
- 未提供
研究组 & 干预措施
Vitamin D3 40µg
干预措施: cholecalciferol (D3) (Dietary Supplement)
Vitamin D3 10µg
干预措施: cholecalciferol (D3) (Dietary Supplement)
Vitamin D3 30µg
干预措施: cholecalciferol (D3) (Dietary Supplement)
结局指标
主要结局
S-25OHD concentration after vitamin D supplementation to infants
时间窗: after 10 weeks of supplementation
The primary endpoint is the concentration of 25OHD in serum after daily supplementation with vitamin D (10µg / 30µg / 40µg orally). Vitamin D supplementation is given to infants from 2 weeks of age to 3 months of age.
次要结局
- concentration of calcium in the plasma and in the urine(after 10 weeks of supplementation)
- bone mineral density(after 10 weeks of supplementation)