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临床试验/NCT02569593
NCT02569593Unknown不适用

Evaluation of the Absorption Rate From Different Oral Fe-supplements in Obese Volunteers Pre- and Post-RYGB: an Interventional Study

KU Leuven1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
KU Leuven
入组人数
15
试验地点
1
主要终点
The absorption rate from different oral Fe-supplements

研究概览

简要总结

Obese volunteers who have scheduled a gastric bypass (RYGB) in UZ Leuven will be asked to participate in a cross-over study using commercial available iron supplements. The aim of this study is to evaluate the absorption rate of different oral iron supplements in volunteers before and after RYGB (1, 3, 6 and 12 months post-RYGB).

详细描述

Patients who met the criteria will be invited to come to the clinical research center at 10 occasions (two times before and 1, 3, 6 and 12 months after RYGB). During each visit the following information will be collected:

  • General information concerning sociodemographic and medical background
  • The medical history
  • Anthropometric measures
  • Physical activity by questionnaire
  • Food frequency by questionnaire
  • Information about menstrual blood loss.

Following an overnight fast, subjects will come to the clinical research center. An intravenous catheter will be inserted to collect blood samples. Before the oral administration, blood samples will be collected for the determination of the serum concentration of different iron status markers. The volunteers will receive first an iron(II)sulfate supplement, followed by a Fe-chelate supplement (at least 7 days between both supplements). After the administration of the supplement, blood samples will be taken at various time points to determine the amount of iron absorption and to investigate if there are any changes in the iron metabolism (at 15, 30, 60, 90 minutes and 2; 2.5; 3; 3.5; 4 and 5 hours after oral administration). There will be a one-week washout period between the tests with each iron supplement. The volunteers will be asked to repeat the test before surgery and 1, 3, 6 and 12 months after surgery for each iron supplement.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Obese patients who have planned a RYGB surgery in the University Hospital Leuven
  • •Low iron status at the preoperative consultation (ferritin < 30 µg/L and/or transferrin saturation <20%)

排除标准

  • •Patients with a bariatric surgery history
  • •Smokers (> 15 cigarettes/day)
  • •Pregnant women
  • •Lactating women
  • •Patients with a positive helicobacter pylori screening

研究组 & 干预措施

RYGB-patient

Other

Patients with a planned RYGB at UZ Leuven will be recruited. Iron supplements, more specific Ferrodyn and Vista Ferrum will be administrated in these patients before and 1, 3, 6 and 12 months post-RYGB with at least 7 days between the administration of the different supplements.

干预措施: Iron supplements, more specific Ferrodyn and Vista Ferrum (Dietary Supplement)

结局指标

主要结局

The absorption rate from different oral Fe-supplements

时间窗: One year

The rate and extent of absorption of iron wille be estimated by changes in serum iron concentration.

次要结局

未报告次要终点

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ina Gesquiere

PharmD-PhD

KU Leuven

研究点 (1)

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