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临床试验/NCT05835648
NCT05835648尚未招募不适用

Effect of Dietary Fiber on Anemia and Glomerular Filtration Rate in Non-dialysis Patients With Chronic Kidney Disease

Qianfoshan Hospital0 个研究点目标入组 56 人开始时间: 2023年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
56
主要终点
Changes in baseline hemoglobin levels at 9 months

研究概览

简要总结

The main objective of this study was to investigate the effect of dietary fiber on anemia and glomerular filtration rate in non-dialysis patients with chronic kidney disease. Participants will be randomly divided into a dietary fiber intervention group and a blank control group. The patients in the dietary fiber intervention group will have dietary fiber intake survey conducted by dietitians on the basis of basic treatment. Supplemented dietary fiber was given on the basis of daily diet, once a day, 1 piece each time, before meals, and the intervention lasted for 3 months. The blank control group was followed up without intervention. Clinical data, blood, urine and stool samples were collected at the initial diagnosis and at each follow-up site.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Above 18 years old;
  • Clinically confirmed (history, blood creatinine, kidney B-ultrasound, laboratory examination, etc.) as stage 3-5 chronic kidney disease, endogenous creatinine clearance was < 60ml/min according to Cockcroft-Gault formula;
  • Generally in good condition, have a good understanding of their own illness and physical condition, have self-awareness, and can communicate well with others;
  • Hemoglobin 100-130g/L;
  • In a non-dialysis state.
  • Dietary fiber intake <25g/d;
  • Voluntarily join the study, understand the significance of the test and the indicators to be measured, and sign the informed consent.

排除标准

  • Unwilling to join the study; Severe infection: fever, cough and sputum, pharyngeal pain, abdominal pain, diarrhea, carbuncle and other skin and soft tissue infection and other clinical manifestations, blood routine white blood cell count beyond the normal range (10×109/L);
  • Severe cardiovascular diseases: including chronic cardiac insufficiency grade 3 or above and various arrhythmias;
  • Obvious hypoproteinemia: albumin less than 30g/L;
  • Corrective measures for anemia (blood transfusion, erythropoietin, HIF-PHI, iron supplement) have been applied in the past 3 months;
  • Tumor evidence: certain tumors have been detected or clinical manifestations and tumor markers suggest the possibility of tumor;
  • Pregnant women;
  • Recent history of heavy blood loss.

结局指标

主要结局

Changes in baseline hemoglobin levels at 9 months

时间窗: 9 months

Changes of glomerular filtration rate at baseline at 9 months

时间窗: 9 months

次要结局

未报告次要终点

研究者

发起方
Qianfoshan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zunsong Wang

Clinical professor

Qianfoshan Hospital

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