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临床试验/NCT00069134
NCT00069134已完成不适用

Glutathione Homeostasis and Oxidant Damage in Kwashiorkor

Baylor College of Medicine1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2003年6月1日最近更新:
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
86
试验地点
1
主要终点
small intestine, skin function and red blood cell gluathione synthesis

研究概览

简要总结

It is believed that the organs of severely malnourished children malfunction because harmful compounds called oxidants injure the tissues in these organs. In a healthy person oxidants are made harmless because another compound called glutathione neutralizes them. Glutathione is made from three amino acids that we get from the protein we eat in our food. We found that malnourished children were not making enough glutathione because they lacked one of these amino acids called cysteine. In this study we determine why malnourished children do not have sufficient cysteine, and we will feed malnourished children a whey-based diet which is rich in cysteine during their treatment to determine whether they will make more glutathione. This in turn may make their organs recover faster. These findings will let us know whether malnourished children can recover faster if they are given more cysteine during the early phase of treatment.

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
Double (Participant, Investigator)

入排标准

年龄范围
6 Months 至 18 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Infants and toddlers, 6-18 months of age
  • •Suffering from severe protein-energy malnutrition, kwashiorkor and marasmic-kwashiorkor

排除标准

  • 未提供

研究组 & 干预措施

Sulfur Amino Acids

Experimental

12 children with edematous severe malnutrition will be assigned to receive 0.65 mmol/kg/d of sulfur amino acids. Supplements will be added to the children's daily diets.

干预措施: sulfur amino acids (Dietary Supplement)

Alanine

Placebo Comparator

12 children with edematous severe malnutrition are assigned to receive 0.65 mmol/kg/d of alanine as placebo. Supplements will be added to the children's daily diets.

干预措施: sulfur amino acids (Dietary Supplement)

结局指标

主要结局

small intestine, skin function and red blood cell gluathione synthesis

时间窗: after intervention

The effect of dietary supplementation with either a mixture of SAAs or alanine (controls) on: 1. buccal tissue protein synthesis, small intestine structure, integrity and function (i.e. mixed mucosal and mucins protein synthesis rate, mucosal GSH synthesis and concentration, villous height and area and crypt depth, intestinal absorptive capacity and degree of mucosal leakiness, and synthesis of the starch digestive enzymes sucrase-isomaltase and maltase-glucoamylase, plus in vivo starch digestion and absorption) in groups of age- and gender-matched children with edematous SCU in the severely malnourished state. 2. skin protein synthesis rate, rate of closure of skin lesions 3. Red blood cell glutathione synthesis rate and cysteine production

immune capacity

时间窗: after intervention

synthesis rate of selected acute phase proteins

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Farook Jahoor

Professor

Baylor College of Medicine

研究点 (1)

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