Oral Nutritional Supplementation in Hospital Patients
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 14
- 主要终点
- Body Weight
研究概览
简要总结
Study Objective: To evaluate the benefits of ONS plus Dietary Counseling (DC) in newly admitted hospital subjects with moderate or severe malnutrition. Number of Subjects / Length of Participation : Approximately 212 subjects (men and women) from multiple Institutions in India will participate in this study. The duration for subject evaluation is 12 weeks. Expected total duration for the study is approximately 9 months. Study Design : Prospective, controlled, randomized, parallel-design, multi-center trial Eligible subjects will be randomized into 2 treatment groups 1.Dietary Counseling only (n=106) 2.Dietary Counseling + ONS (n=106). Primary Outcome : Change in body weight from baseline Secondary Outcomes : Subjective Global Assessment (values and change from baseline) Body Mass Index (values and changes from baseline) Blood chemistries (values and changes from baseline)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject 1.Is greater than or equal 18 years of age 2.Is recently admitted into hospital less than or equal to 36 hrs.
- •3.Identified as having moderate malnutrition or severe malnutrition.
- •4.Has anticipated length of hospital stay of at least 3 days.
- •5.Has a life expectancy of grater than or equal to 12 weeks 6.Is able to consume foods and beverages orally.
- •7.Is willing to abstain from additional non-study provided protein supplements or nutritional supplements throughout the study period.
排除标准
- •Subject 1.has 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, in the opinion of the Study Physician, at study entry.
- •2.has a diagnosis of diabetes, burn injury covering greater than or equal to 15% of the body, advanced renal or hepatic disease (including cirrhosis), active malignancy, including melanoma and excluding cutaneous malignancies (e.g., basal cell carcinoma, squamous cell carcinoma and carcinoma of the cervix).3.has clinically significant ascites, pleural effusion, severe edema or dehydration as determined by a physician.4.Severe edema is defined as Stage
- •5.is currently taking medications/ supplements/substances that could profoundly modulate metabolism or weight (e.g. diuretics, appetite stimulants, progestational agents, steroids, growth hormone, dronabinol, marijuana, or other anabolic agents).6.Exceptions: Inhaled steroids for asthma or chronic obstructive pulmonary disease will be allowed.
- •Topical or optical steroids will also be allowed.
- •In addition, stable doses of steroids or diuretics taken for greater than or equal to 6 weeks prior to hospitalization and maintains the stable dosage for the duration of the study will be allowed.7.has active tuberculosis, acute Hepatitis B or C, or HIV (per documentation in the medical record).
结局指标
主要结局
Body Weight
时间窗: at base line, weeks 4, 8 and12
次要结局
- Nutrition Assessment,BMI and Blood Chemistries(Nutrition Assessment and BMI at baseline and week 12 and Blood Chemistries at baseline and weeks 4,8,12)