Effect of Neutralization of Endogenous Acid Production on Bone Mineral Density and Microarchitectural Composition of Bone in Humans
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- BMD at L2-L4 by DEXA and microarchitectural composition of bone in both tibias and radius
研究概览
简要总结
Hypothesis: Neutralization of acid production induced by the Western diet with oral administration of potassium citrate increases bone mineral density and bone mass as well as skeletal muscle mass and strength in elderly people (> 65y).
详细描述
We will perform a prospective, randomized, placebo-controlled trial evaluating the effect of K citrate on bone mineral density, microarchitectural composition of bone,nutritional parameters, lean body mass, parameters of skeletal muscle mass and strength, 24h and exercise induced blood pressure changes in otherwise healthy, elderly ambulatory subjects of both genders.
Potassium citrate (60 mEq) is supplied as tablets with a wax matrix (10 mEq of citrate per tablet) and ingested in three doses/day. All subjects will receive daily oral 500 mg of calcium and 400 IU of vitamin D to ensure adequate calcium and vitamin D supply.
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
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women, 65 to 80y, tscores at L2-L4 0 to -2.5
排除标准
- •Treated or necessity to treat low BMD (t-score L2 to L4 <-2.5)
- •Any major medical illness that would possibly need hospitalization and/or be followed by foreseeable complications within 12 months and/or have a life-expectancy of less than 5 years
- •Stable serum creatinine > 150 umol/l and/or known Type IV renal-tubular acidosis (hyperkalemia)
- •vegetarians
- •concommitant drug prescriptions: systemic and topical glucocorticoids, systemically acting estrogens (topical allowed): both within the last 6 months. antiosteoporosis drugs: bisphosphoponates, fluoride, calcitonin, all within the previous 12 months.
- •vitamin D deficiency at screening visit
- •technical difficulties to delineate bone area of interest during the screening visit
研究组 & 干预措施
Potassium citrate
干预措施: potassium citrate (Drug)
结局指标
主要结局
BMD at L2-L4 by DEXA and microarchitectural composition of bone in both tibias and radius
时间窗: 12 and 24 months
次要结局
- Effect on BMD at hip and total body Effect on 24h ambulatory blood pressure(12 and 24 months)
- effect on skeletal muscle mass and strength(12 and 24 months)
- effect on left ventricular muscle mass(24 months)
- effect on carotid media-intima thickness(24 months)
- Hypoxia-induced endothelial vasorelaxation(24 months)
研究者
Reto Krapf
Professor of Medicine
Kantonsspital Baselland Bruderholz