Effect of 1 Year Vitamin D or D Plus B-vitamins on Bone Markers in Elderly People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Changes in bone formation markers
研究概览
简要总结
The standard recommendation to prevent osteoporosis is to supplement low doses of vitamin D and calcium. Hyperhomocysteinemia has been related to increased risk of osteoporosis.
详细描述
The current study aimed at investigating if homocysteine-lowering effect (low doses of B-vitamins) will add any measurable beneficial effect on bone markers when added to the standard recommendations for prevention of osteoporosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age> 50 years,
- •male and female
排除标准
- •renal dysfunction,
- •recent stroke or coronary event within the last 3 months,
- •current cancer,
- •antifolate treatment,
- •ileum resection,
- •existing B vitamins supplementation,
- •megaloblastic anemia,
- •osteoporotic patients treated with pharmacological doses of vitamin D or antiosteoporotic drugs.
- •Termination criteria were:
- •indication for a high-dose vitamin B supplementation,
- •coronary or vascular event,
- •or surgical procedures during the study.
研究组 & 干预措施
Vitamin D, Calcium, Vitamins B9, B6, B12
a combination of dietary supplement including "all" 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate plus 0,5mg Folic acid, 50 mg B6, 0,5 mg B12
干预措施: Vitamin D, Calcium, Vitamins B9, B6, B12 (Dietary Supplement)
Vitamin D and Calcium
a combination of dietary supplement including "all" 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate
干预措施: Vitamin D and Calcium (Dietary Supplement)
结局指标
主要结局
Changes in bone formation markers
时间窗: baseline, 6 and 12 months
Concentrations of bone formation markers in plasma \[OC (ng/ml), BAP (U/L)\]: are measured: if all are increased indicate enhanced bone formation
次要结局
- Changes in global DNA methylation(baseline and after 12 months)
- Changes in concentrations of bone resorption markers(baseline, 6 and 12 months)
- Changes in plasma choline and betaine(baseline and aftter 12 months)
- Changes in gene-specific gene methylation(baseline and after 12 months)
- Changes in TMAO(baseline and after 6 and 12 months)
- Changes in phospholipid concentration in plasma(baseline and after 12 months)
- Changes in plasma homocysteine concentrations(baseline, 6 and 12 months)
- Changes in plasma levels of folate(baseline, 6 and 12 months)
研究者
Rima Obeid
Prof. (apl.) Dr.
Universität des Saarlandes