跳至主要内容
临床试验/NCT06464718
NCT06464718已完成不适用

Effectiveness of Calcium and Vitamin D, With and Without Collagen Peptide, in Enhancing Bone Mineral Density on Postmenopausal Women With Osteopenia: Pilot Randomized Controlled Trial.

Frontier Medical and Dental College, Abbotabad1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年6月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Blood Test

研究概览

简要总结

Osteopenia is characterized by bone mineral density (BMD) being lower than normal but not reaching the osteoporosis threshold, poses a serious problem for women after menopause. Osteopenia is a precursor to osteoporosis that is associated with increased risk of fractures, morbidity, and mortality. Using strategies to improve or maintain bone density is important for preventing osteoporosis and its associated complications. The combination of collagen peptide (CP) with calcium and vitamin D supplementation may provide several ways to improve bone health. This study aims to provide preliminary evidence of the effectiveness of traditional medicine in improving bone health through the effectiveness of CP.

详细描述

Osteopenia is characterized by bone mineral density (BMD) being lower than normal but not reaching the osteoporosis threshold, poses a serious problem for women after menopause. Osteopenia is a precursor to osteoporosis that is associated with increased risk of fractures, morbidity, and mortality. Using strategies to improve or maintain bone density is important for preventing osteoporosis and its associated complications. The combination of collagen peptide (CP) with calcium and vitamin D supplementation may provide several ways to improve bone health. This study aims to provide preliminary evidence of the effectiveness of traditional medicine in improving bone health through the effectiveness of CP.The study was single blinded randomized controlled trial, involving 30 post-menopausal women that were equally divided into two groups by computer generated simple random sampling technique. Group A received bioactive collagen peptide along with calcium lactate, and vitamin D3. The control group (Group B) consisted of 15 participants who were given a chewable tablet daily, containing 1.25 grams of calcium carbonate (equivalent to 500 mg of elemental calcium) and 400 IU of vitamin D3.

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
40 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Postmenopausal patients
  • 0>T-score>-

排除标准

  • fracture,
  • primary hyperparathyroidism

研究组 & 干预措施

Fortibone

Experimental

干预措施: Fortibone (Drug)

Chewable Tablet

Active Comparator

干预措施: Chewable Tablet (Drug)

结局指标

主要结局

Blood Test

时间窗: baseline and after 3 months

Osteocalcin

Dexa Scan

时间窗: baseline and after 3 months

Bone Mineral Density

次要结局

未报告次要终点

研究者

发起方
Frontier Medical and Dental College, Abbotabad
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Saif ur Rehman

Professor

Frontier Medical and Dental College, Abbotabad

研究点 (1)

Loading locations...

相似试验