NCT03462056已完成1 期
Pilot Study of Ready to Use Therapeutic Food to Promote Weight Gain in Cystic Fibrosis
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- BMI Z-score
研究概览
简要总结
Children with cystic fibrosis require increased caloric intake to maintain appropriate growth, an important determinant of long-term outcomes. This study seeks to determine the feasibility of using a novel therapeutic food to promote weight gain and growth in children with cystic fibrosis.
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
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cystic Fibrosis diagnosed by sweat test or genetic testing.
- •Exocrine Pancreatic Insufficiency and receiving pancreatic enzyme replacement therapy
- •BMI or weight for age of less than the 50th percentile
排除标准
- •Cystic fibrosis related diabetes mellitus
- •Cystic fibrosis related liver disease.
- •Anaphylactic or other allergy to peanut, cow's milk, oat flour or other RUTF ingredients.
- •Patients who are status-post lung or liver transplantation
- •Currently receiving enteral supplemental nutrition through gastrostomy or nasogastric tube.
研究组 & 干预措施
CF Ready to Use Supplemental Food.
Experimental
Participants will receive Cystic Fibrosis Ready to Use Supplemental Food sufficient to provide approximately 20% of estimated daily caloric needs up to 500kcal of total calories, 18.5 grams of protein and 28g of fat. The supplement is also optimized to provide excellent protein quality and optimal polyunsaturated fatty acid composition
干预措施: Cystic Fibrosis Ready to Use Supplemental Food (Dietary Supplement)
结局指标
主要结局
BMI Z-score
时间窗: 3 months
Change in BMI Z-score
次要结局
- Pulmonary Function(3 months)
- Weight Z-score(3 months)
- Quality of Life(3 months)
- Compliance of taking supplemental food(3 months)
- Body Composition(3 months)
研究者
研究点 (2)
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