Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury - a Placebo-controlled Randomized Double-blinded Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Vitamin D status
研究概览
简要总结
The main objective of this placebo-controlled randomized double-blinded study is to investigate the effect of vitamin D supplementation on vitamin D status (25(OH)D concentration in the blood) among individuals with a chronic spinal cord injury (SCI). Further, the effects of vitamin D supplementation on several other parameters (e.g. bone density and mood) are investigated, which could reveal positive secondary effects of supplementation that are especially relevant for clinical practice.
详细描述
The purpose of this study is to evaluate the influence of vitamin D supplementation among individuals with chronic SCI. The primary aim is to study whether different dosages (24'000 IU/month or 48'000 IU/month) of vitamin D supplementation over 12 months will lead to differences in vitamin D status as well as differences in several other outcomes. The use of a placebo group supports the evaluation of dose-response effects of vitamin D supplementation on the primary outcome (vitamin D status) and secondary outcomes (including bone density and mood) that are not only supported by randomized controlled trial standards but also informative in clinical practice.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent to the present study as documented by a signature
- •Chronic (> 3 years) traumatic or non-traumatic spinal cord injury with a sub-C4-level lesion
- •Wheelchair dependency during activities of daily living
- •vitamin D status <75nmol/L
排除标准
- •Contraindications to the investigational product
- •Clinically relevant disorders,
- •Pressure ulcer grade 3 or 4
- •Pregnancy, breastfeeding
- •Vitamin D supplementation (> 400 IU/day) within the last 12 months
- •Visiting a country with increased sun exposure (below the 37th parallel north) within the last month before study enrolment or during the study
- •Fractures in both arms and/or both legs within the last five years
研究组 & 干预措施
"Low" dose
One vial with 600 µg cholecalciferol (corresponding to a total of 24'000 IU vitamin D) and one vial with placebo every month.
干预措施: Cholecalciferol (Vitamin D3) (Drug)
"Low" dose
One vial with 600 µg cholecalciferol (corresponding to a total of 24'000 IU vitamin D) and one vial with placebo every month.
干预措施: Placebo (Other)
"High" dose
Two vials with 600 µg cholecalciferol each (corresponding to a total of 48'000 IU vitamin D) every month.
干预措施: Cholecalciferol (Vitamin D3) (Drug)
Placebo
Two vials with a placebo every month.
干预措施: Placebo (Other)
结局指标
主要结局
Vitamin D status
时间窗: 0 to 12 months
Serum levels of 25(OH)D in nmol/L
次要结局
- Bone density(At baseline and after 12 months)
- Chronic pain(At 0, 3, 6, 9, 12 months)
- Recent pain(At 0, 3, 6, 9, 12 months)
- Pressure injuries(At 0, 3, 6, 9, 12 months)
- Mood(At 0, 3, 6, 9, 12 months)
- Fatigue(At 0, 3, 6, 9, 12 months)