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临床试验/ISRCTN34051237
ISRCTN34051237已完成未知

A double blind placebo controlled parallel trial of soy isoflavones on markers of bone turnover in females in the early menopause

Hull and East Yorkshire Hospitals NHS Trust (UK)0 个研究点目标入组 200 人开始时间: 2012年9月5日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
200

研究概览

简要总结

  1. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29739677 2. 2018 results relating to thyroid hormone effects in https://www.ncbi.nlm.nih.gov/pubmed/30524380

研究设计

研究类型
Interventional

入排标准

性别
Female

入选标准

  • 1. Women with a follicle-stimulating hormone (FSH) and luteinizing hormone (LH) greater than 20 mU/L and amenorrhoea for 1 year with or without vasomotor instability of hot flushing will be eligible to participate
  • 2. Caucasian women

排除标准

  • 1. Patients with liver dysfunction (ALT of greater than 135 u/L) or taking drugs that may interfere with liver function
  • 2. Patients with impaired renal function (creatinine greater than 150, glomerular filtration rate less than 30)
  • 3. Patients who have had antibiotic treatment within the last 6 months will also be ineligible for the study as antibiotics are known to change gut microflora and thus will interfere with phytoestrogen metabolism. This will also mean that patients who start taking antibiotics during the study will have to be withdrawn
  • 4. Patients not wishing to allow disclosure to their GPs
  • 5. Patients on any medication within 3 months of the study including steroid inhalers or HRT
  • 6. Patients already self-supplementing with isoflavones
  • 7. Vegetarian or vegans

研究者

发起方
Hull and East Yorkshire Hospitals NHS Trust (UK)

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