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临床试验/NCT05869422
NCT05869422已完成不适用

Randomised, Double-blind, Placebo-controlled Clinical Trial Evaluating the Effectiveness of a Low-dose Iron Supplementation in Non-anaemic Iron-deficient Women

Dr. Krayenbühl GmbH2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2024年5月6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
59
试验地点
2
主要终点
Serum-ferritin change

研究概览

简要总结

The goal of this study is to investigate the efficacy of a low dose iron supplement (6mg) compared to a placebo tablet.

详细描述

The established therapy for iron-deficiency today is oral iron supplementation. However, this often leads to side effects such as constipation, black stools, nausea, and abdominal pain. There are some studies that have compared the efficacy of low-dose iron with normal-dose iron. These showed that the side effects are dose-dependent. Furthermore, some studies have shown that the uptake capacity of high-dose iron is less efficient due to the upregulation of hepcidin. In a pilot study with low-dose iron (6mg per tablet), a significant increase in iron was shown, which can be explained by a lower hepcidin release. Therefore, the investigators would like to show the efficacy of the low-dose iron product in a placebo-controlled setting. Furthermore, the goal is to examine the reduction of side effects before and after administration of the iron and placebo tablet. Additionally, a potential increase of low blood pressure to normal blood pressure will be investigated. There will be two groups of women: one group will be given a low-dose iron supplement of two tablets containing each 6mg for 2 months (60 days), the other one will get two placebo tablet for 2 months, accordingly.

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
Double (Participant, Investigator)

盲法说明

study employees

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • informed consent as documented by signature
  • female gender
  • premenopausal
  • age > 18 years
  • regular menstrual cycle
  • BMI in normal range (18-25 kg/m²)
  • serum-ferritin ≤30µg/l
  • no anaemia (Hemoglobin ≥117g/l)
  • no intake of dietary supplements containing iron (last 4 weeks)
  • the participant is linguistically and cognitively able to understand the study procedure

排除标准

  • Current pregnancy
  • breastfeeding
  • hypermenorrhea (more than 5 unties/tampons per day)
  • chronic inflammatory diseases (e.g. colitis)
  • psychiatric disorders
  • chronic kidney disease (creatinine >80 µmol/l)
  • liver disease (ALT >35 U/l)
  • increased CRP (>5mg/l)
  • hypersensitivity to iron-supplements
  • intake of medicines that interact with oral iron supplementation (e.g. PPI)

结局指标

主要结局

Serum-ferritin change

时间窗: 60 ± 5 days

significant change of serum-ferritin under supplementation

次要结局

  • Blood Pressure(60 ± 5 days)
  • Blood Sugar(60 ± 5 days)
  • Lipid Status(60 ± 5 days)

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Albina Nowak

PD Dr. med.

University of Zurich

研究点 (2)

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