跳至主要内容
临床试验/NCT05810909
NCT05810909已完成不适用

Effects of Amorphous Calcium Carbonate Supplementation on Bone Health Based on Bone Mineral Density and Bone Turno-ver Markers: A Randomized, Double-Blind, Placebo-Controlled Parallel-Group Trial in Postmenopausal Women With Osteopenia

Universal Integrated Corp.2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
bone density change

研究概览

简要总结

This research was designed in accordance to the Method for Efficacy Assessment of Health Food for Bone Heath. Changes to bone density were measured to evaluate the effectiveness of amorphous calcium carbonate in maintaining bone health.

详细描述

Bone comprises organic matter, predominantly protein, and inorganic matter including various mineral salts. Inappropriate nutrition profile can affect the balance of bone metabolism and cause bone loss. Of all nutrients, calcium is considered the most important for bone structure and metabolism. It is the most common deficit that affects bone health. Low dietary calcium intake can lead to negative calcium balance. Low blood calcium (< 10mg/dL) induces the release of parathyroid hormone (PTH), which activates the conversion process of 25-(OH)-D3 to physiologically active 1,25-(OH)2-D3 in kidneys. PTH and 1,25-(OH)2-D3 act jointly to change the ionic valence of hydroxyapatite, converting orthophosphate to pyrophosphate. This causes hydroxyapatite to easily dissociate and release calcium ion in order to compensate the blood calcium level. This is called bone resorption. While this physiological mechanism maintains blood calcium homeostasis, it also causes bone loss that can develop into osteoporosis. Negative calcium balance is not only caused by lack of dietary calcium, hormonal abnormality or vitamin D deficit may also lead to negative calcium balance and the development of osteoporosis. This study aims to assess the effects of UIC Amorphous Calcium on osteoporosis with "Bone Change Test" and "Calcium Bioavailability Test".

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)

盲法说明

A Randomized, Double-Blind Trial

入排标准

性别
Female
接受健康志愿者

入选标准

  • Menopausal women were recruited (those who had just started menopause or less than 10 years post-menopause were preferred).

排除标准

  • respiratory insufficiency,
  • sleep apnea,
  • gastroesophageal reflux,
  • neurological or liver disease,
  • malignant tumor, alcohol abuse,
  • hysterectomy or hormonal therapy,
  • and depressive symptoms.

结局指标

主要结局

bone density change

时间窗: 6 months

monitoring bone mineral density change and bone turnover markers change

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验