Vitamin D Supplementation in Elderly Nursing Home Residents: Daily Supplementation Compared to a Loading Dose an Monthly Supplementation, a Randomised Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Proportion of patients reaching an adequate serum 25(OH)D level (75-150 nmol/l)
研究概览
简要总结
Vitamin D deficiency is common in older persons, in particular in residents of nursing homes. This is mainly explained by the fact that older persons do not often go outside in the sunshine. On top of that the capacity of the skin to synthesize provitamin D is decreased and dietary vitamin D intake is low. Vitamin D deficiency leads to osteoporosis, falls and fractures. To prevent morbidity and mortality due to falls and fractures it seems logical to supplement vit D in order to correct the deficiency. The advised daily dose of vit D supplementation is 800 IU. Several studies showed that with this dose the required serum 25(OH)D levels will not be reached.
primary objective of this study is:
- to investigate whether with a loading dose based on body weight and baseline serum 25(OH)D level more patients reach adequate serum 25(OH)D levels compared to 800 IU a day.
- to determine the best consolidation treatment.
Secondary objective
- is a loading dose based on body weight and baseline serum 25(OH)D level safe to use in residents of nursing homes.
- is there a relation between the increase in serum 25(OH)D level and muscle strength (handgrip strength).
- is there a relation between the increase in serum 25(OH)D level and mobility (2 minute walk test).
Study design:
Randomised trial with 3 study groups:
- Group 1a. loading dose based on body weight and baseline serum 25(OH)D level + 50.000 IU vit D3/month consolidation therapy.
- Group 1b. loading dose based on body weight and baseline serum 25(OH)D level + 25.000 IU vit D3/month consolidation therapy.
- Group 2. 800 IU vit D3/ dag.
Study population:
Vitamine D deficient residents of nursing homes, 65 years or older.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Long term indication for living in a residential home for the elderly
- •Age > 65 years
- •Vitamin D deficiency (serum 25- hydroxycholecholecalciferol (25(OH)D3 < 50 nmol/l)
- •Informed Consent
排除标准
- •Hypercalcemia (serum CA > 2.60 mmol/l)
- •Life expectancy < 1/2 year
- •Multivitamin use including > 400 IE vit D
- •Non-functional dominant arm
结局指标
主要结局
Proportion of patients reaching an adequate serum 25(OH)D level (75-150 nmol/l)
次要结局
- Proportion of patients reaching a serum 25(OH)D level > 220 nmol/l
- Handgrip strength
- Distance achieved in a 2 minute walk test