NCT01641770已完成3 期
Oral Nutritional Supplementation in Hospital Patients
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 13
- 主要终点
- Changes from baseline in Body weight
研究概览
简要总结
The study objective is to evaluate the benefits of Oral Nutritional Supplementation (ONS) plus Dietary Counseling (DC) in newly admitted hospital subjects with moderate or severe malnutrition.
详细描述
Approximately 212 subjects (men and women) from multiple Institutions in India will participate in this study. Eligible subjects will be randomized into 2 treatment groups.
- Dietary Counseling only (n=106)
- Dietary Counseling + ONS (n=106)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Recently admitted into hospital ≤36 hrs.
- •Identified as having "moderate malnutrition" or "severe malnutrition".
- •Anticipated length of hospital stay of at least 3 days.
- •Life expectancy of ≥ 12 weeks
- •Able to consume foods and beverages orally.
- •Willing to abstain from nutritional supplements throughout the study period unless provided be study.
排除标准
- •Alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, dysphagia, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances.
- •Diabetes, burn injury covering greater than or equal to 15% of the body, advanced renal or hepatic disease, active malignancy.
- •Ascites, pleural effusion, severe edema or dehydration.
- •Severe edema.
- •Medications/ supplements/substances that could profoundly modulate metabolism or weight
- •Active tuberculosis, acute Hepatitis B or C, or HIV.
结局指标
主要结局
Changes from baseline in Body weight
时间窗: baseline and weeks 4, 8, 12
次要结局
- Nutrition Assessment(baseline and week 12)
- BMI(baseline and week 12)
- Blood Chemistries (pre-albumin g/L, alpha-1 acid glycoprotein g/L)(baseline and weeks 4,8,12)
- Blood Chemistries (albumin gm/dL, hemoglobin gm/dL, total protein gm/dL)(baseline and weeks 4, 8, 12)
- Blood Chemistries (glucose mg/dL, creatinine mg/dL)(Baseline and weeks 4,8,12)
- Blood Chemistries (c-reactive protein mg/L)(Baseline and weeks 4,8,12)
研究者
研究点 (13)
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