NCT01011608已完成3 期
Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Hip Fracture Surgery
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 21
- 主要终点
- Blood chemistry
研究概览
简要总结
The objective of this study is to evaluate the effect of nutritional supplementation on the nutritional and clinical course of patients admitted to the hospital for hip fracture surgery.
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
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is > 45 years of age.
- •Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
- •Subject plans to undergo hip fracture surgery.
- •Subject has anticipated length of hospital stay of at least 4 weeks. Subject is able to consume foods and beverages orally.
- •Subject has admission total protein ≤ 70 g/L.
- •Subject has screening serum albumin ≤ 38 g/L.
排除标准
- •Subject is known to be allergic or intolerant to any ingredient found in the study product.
- •Subject has pre-planned surgery other than hip fracture surgery during the study period.
- •Subject has alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances.
- •Subject has active malignancy
- •Subject has chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •Subject has diagnosis of IDDM.
- •Subject has uncontrolled NIDDM determined by HbA1c > 8%.
结局指标
主要结局
Blood chemistry
时间窗: 28 days
次要结局
- Product intake(28 days)
- Functionality (pain, mobility, strength)(28 days)
- Surgical site status(28 days)
研究者
研究点 (21)
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