IRONCARE: Iron Treatment in Older Patients With Hip Fractures - A Double-blinded Placebo-controlled Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 528
- 试验地点
- 5
研究概览
简要总结
The aim of this study is to investigate the effects of intravenous (IV) iron therapy compared to alternate-day oral iron treatment and no supplementation in older patients with hip fractures. This study will examine the impact of iron treatment on fatigue, functional decline, fear of falling, cognitive impairment, and quality of life, as well as its effects on iron stores and hemoglobin levels, with the overall goal of improving postoperative rehabilitation.
The trial will be conducted on five different hospitals in the Central Region of Denmark (Region Midtjylland).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hip fracture (ICD-10 codes: DS720, DS721 and DS722)
- •Low energy trauma
- •Age ≥ 75 years
- •Hemoglobin ≤7.0 mmol/L (11 g/dL) during hospital admission
排除标准
- •Pathological fracture
- •Periprosthetic fracture
- •Inability to understand or speak Danish
- •Dysphagia and thus inability to swallow study medication
- •Signs of iron overload, hemochromatosis, or hemosiderosis
- •Liver disease (cirrhosis or hepatitis) and transaminase levels >3 times upper limit of normal
- •Known allergy to iron formulations
- •Severe asthma
- •Severe hypophosphatemia: <0.35 mmol/L
- •Patients already receiving iron supplementation that cannot be paused for the study period
- •Cognitive impairment that results in either memantine-treatment or a Short Portable Mental Status Questionnaire (SPMSQ) score > 4
研究组 & 干预措施
IV Iron
Intravenous iron once and placebo tablets on alternate days for 90 days
干预措施: Placebo Tablets (Drug)
Oral Iron
Intravenous sodium chloride once and ferro sulfate tablets on alternate days for 90 days
干预措施: Oral Iron (Ferrous sulphate) (Drug)
Oral Iron
Intravenous sodium chloride once and ferro sulfate tablets on alternate days for 90 days
干预措施: Placebo IV (Drug)
Placebo
Intravenous sodium chloride once and placebo tablets on alternate days for 90 days
干预措施: Placebo IV (Drug)
Placebo
Intravenous sodium chloride once and placebo tablets on alternate days for 90 days
干预措施: Placebo Tablets (Drug)
结局指标
主要结局
未指定
次要结局
- Cognitive impairment(Baseline and days 30 and 90 after discharge)