NCT02046746已完成不适用
The Effect of a Renal Specific Oral Nutritional Supplement on Nutritional Status and Other Outcomes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- Serum Albumin
研究概览
简要总结
The study objective is to evaluate if a renal specific oral nutrition supplement (ONS) aids in maintaining nutritional status.
详细描述
This study is an unblinded, prospective, multicenter, single arm study in Taiwan. Eligible subjects (see inclusion and exclusion criteria in Section 5.2) will receive standard of care (which includes dietary counseling) and ONS supplementation (1-2 servings/day depending on subject's needs) for 24 weeks (6 months). A follow up visit (phone call/medical chart review) will occur 12 months after the study intervention has ended to collect mortality data, to determine whether or not dialysis was initiated, and if ONS use continued.
Subjects will be informed of the study results when available. Subjects may continue use of the commercially available study product if it is recommended by their nephrologist, primary care physician, dietitian, or if the subject chooses.
For this study enrollment is defined as when the subject is stratified and begins to consume the study product (Study Visit 1, Month 0).
The target population described above may be stratified into the following groups (n=18 evaluable/group):
- Male CKD Stage 3b-5 without T2DM
- Male CKD Stage 3b-5 with T2DM
- Female CKD Stage 3b-5 without T2DM
- Female CKD Stage 3b-5 with T2DM
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subject, or subject's legally acceptable representative (LAR), has voluntarily signed and dated an informed consent form (ICF), approved by an IEC/IRB, and provided Health Insurance Portability and Accountability Act (HIPAA)
- •Subject is >18 years of age.
- •Subject has been diagnosed with Chronic Kidney Disease (CKD) and is classified as being between Stages 3b to
- •Subject has an eGFR 45 and 10 ml/min/1.73m2 at screening.
- •Subject is a male or non-pregnant female at least six weeks postpartum and non-lactating.
- •Subject with CKD is either:
- •not diagnosed with Type 2 Diabetes Mellitus (T2DM) OR
- •diagnosed with T2DM and had no changes in glycemic medication (dose or type) for at least 2 months prior to screening
- •Subject has a serum albumin 3.0 g/dl at screening.
- •Subject has a BMI 30 kg/m
- •If diagnosed with T2DM, subject has A1c level 9.0% at screening.
- •Subject is not scheduled or expected to receive dialysis in the next 18 months.
- •Subject's life expectancy is 18 months determined by the study physician.
- •Subject is willing to follow the protocol as described.
- •With regard to ONS use the subject must qualify as one of the following:
- •be naïve to ONS
- •if the subject is already prescribed another ONS that is not the study product, and they have consumed 8 servings over the last 28 days prior to screening, they will undergo a washout period (3 weeks)
- •if the subject is already prescribed the study product, and they have consumed ≤ 8 servings over the last 28 days prior to screening, or have poor daily compliance (< 75%), they will undergo a washout period (3 weeks)
- •if the subject is already prescribed the study product, and they have been consuming 1-2 servings daily, with >75% compliance, for < 3 months, they do not require a washout period, and can be retrospectively included in the study protocol (provided proper records can be obtained)
排除标准
- •Subject has type 1 diabetes.
- •Subject is considered malnourished (SGA = 1 to 3).
- •Subject has received intravenous albumin treatment within the last 6 months.
- •Subject has overt symptomatic peripheral neuropathy, retinopathy, or autonomic neuropathy.
- •Subject has poorly controlled chronic hypertension
- •Subject has had major surgery, inpatient or outpatient, requiring >7 days of hospitalization in the last 3 weeks prior to screening visit,
- •Subject has a known chronic/contagious infectious disease, clotting or bleeding disorder, active malignancy
- •Subject is missing, or has had an amputation of, a limb.
- •Subject has had a significant cardiovascular event
- •Subject has a known obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease
- •Subject is currently diagnosed with, or has a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
- •Subject is currently consuming, or cannot refrain from taking, medications/dietary supplements/herbal preparations or substances,
- •Subject is known to be allergic or intolerant to any ingredient found in the study product.
- •Subject is considered unsuitable for the study based on the study physician's assessment.
研究组 & 干预措施
Oral Nutritional Supplement (ONS)
Experimental
1-2 serving per day of a renal specific oral nutritional supplement
干预措施: Oral Nutritional Supplement (ONS) (Other)
结局指标
主要结局
Serum Albumin
时间窗: Change from Month 0 to Month 6
次要结局
- Quality of Life(Change from Month 0 to Month 6)
- Dietary Intake Compliance(Change from Month 0 to Month 6)
- Body Mass Index(Change from Month 0 to Month 6)
- Subjective Global Assessment(Change from Month 0 to Month 6)
- Appetite(Change from Month 0 to Month 6)
- Hand Grip Strength(Change from Month 0 to Month 6)
研究者
研究点 (4)
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