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临床试验/NCT02390921
NCT02390921已完成4 期

The Effectiveness of Oral Treatment With Liposomated Iron in Patients With Previous Bariatric Surgery Which Are Currently Receiving Chronic Parentheral Therapy With Iron

Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Non-inferiority (change in the levels of Hemoglobin)

研究概览

简要总结

Bariatric surgery is the most effective long-term treatment of morbid obesity treatment, so you can maintain weight loss enduringly with improvement or resolution of comorbidity and mortality reduction. All bariatric surgery techniques in postoperative induce a significant reduction in food intake and / or absorption of nutrients and therefore may be associated with a risk of nutritional deficiency, which increases over the years after surgery. One of the nutrients whose absorption is affected significantly is iron, women of childbearing age segment most vulnerable being. A significant percentage of these women require oral supplementation with high doses of iron and often parenteral treatment is needed for digestive intolerance or therapeutic failure.

Hypothesis: The liposome orally administered iron could represent a therapeutic alternative in women of childbearing age, previously undergone bariatric surgery that currently require parenteral iron therapy.

Objectives: To evaluate the tolerability and efficacy of oral iron liposome female patients previously undergone bariatric surgery that currently require parenteral replacement therapy, as well as the impact on quality of life.

Methods: a single center, open, prospective, interventional, in 40 women of childbearing age, previously undergone bariatric surgery, which currently require intravenous iron therapy chronically. Subjects will be divided into 2 parallel groups: 20 cases and 20 controls matched for age, level of Hb, year after surgery and percentage of weight lost.

Relevance: This study will allow us to identify an alternative treatment with oral iron in the case of patients with severe iron deficiency after bariatric surgery, which currently require parenteral iron therapy due to intolerance to current oral products or therapeutic failure. At the same time it could help reduce healthcare costs and improve the quality of life of these patients, who will not have to enter periodically in solitary day hospital for administration of parenteral iron.

详细描述

This project is proposed with the aim of exploring the efficacy and tolerability of liposome orally administered iron in female patients previously undergone bariatric surgery (gastric bypass) currently receiving parenteral iron therapy chronically.

The hypotheses are:

(i) .- A significant percentage of patients undergoing bariatric surgery have iron deficiency and chronic complication. In the investigators series, approximately 100 women require intravenous iron therapy in a chronic (10% of all patients undergoing bariatric surgery to date), significantly increasing costs.

(ii) .- The liposomal form of iron does not depend on gastric pH and increased bioavailability is not dependent on the presence of the digestive dudodeno circuit.

(iii) .- Increased iron absorption and tolerability allow us to remove chronic intravenous iron therapy in the case of these patients. Thus, majoraria quality of life by reducing healthcare costs and avoiding adverse reactions associated with the procedure.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • In the clinical study will include:
  • women who underwent Y-de-Roux gastric by-pass
  • over 18 years, premenopausal
  • stable weight in the previous 6 months
  • currently receiving parenteral iron therapy regularly in solitary day hospital
  • which have signed the informed consent

排除标准

  • with mobility problems that constrain a marked inactivity
  • with associated disease (chronic obstructive pulmonary cardiac cerebral vascular-disease, illness, accident sequel , severe psychiatric or eating disorder
  • undergoing different surgical techniques to gastric bypass
  • other causes of iron deficiency.

研究组 & 干预措施

Liosomated iron therapy

Active Comparator

Fisiogen Ferro Forte 28mg every day po, during 3 months

干预措施: Fisiogen Ferro Forte (Drug)

Endovenous Iron Therapy

Experimental

Venofer 300mg endovenously every 3 months

干预措施: Venofer (Drug)

结局指标

主要结局

Non-inferiority (change in the levels of Hemoglobin)

时间窗: 3 months

To evaluate the change in the levels of Hemoglobin at 4 and 12 weeks of treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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