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临床试验/NCT03302949
NCT03302949终止不适用

Nutritional Supplement Trial in Patients With Tuberculosis to Improve Anthropometry and Treatment Outcome

University of Aarhus2 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
232
试验地点
2
主要终点
Anthropometry

研究概览

简要总结

Undernutrition at the time of diagnosis of active tuberculosis is a risk factor for increased mortality, and lack of weight gain during anti-tuberculous treatment has been linked to an increased relapse risk. The purpose of this study is to test the effect of Lacprodan® DI-8090 whey protein concentrate on anthropometric measures, treatment outcome and health-related quality of life, against standard practice during anti-tuberculous treatment on patients with a BMI <20 living in Guinea-Bissau.

详细描述

It is hypothesized that patients with tuberculosis receiving whey protein concentrate as nutritional supplement will experience a greater gain in adverse anthropometric measures, and experience a decreased risk of relapse and death, compared with patients with tuberculosis, who do not receive nutritional supplement. 260 patients will be recruited from and included/randomized at 4 trial sites in Bissau, Guinea-Bissau (Bandim Health Center, Belem Health Center, Cuntum Health Center and Hospital Raoul Follereau). Patients randomized to the intervention arm will receive one package of whey protein concentrate (approx. 62.5g) per day for the duration of the 6-month long anti-tuberculous treatment. Patients will be followed bimonthly during the treatment period, with clinical examinations, blood sample analyses, and nutritional status and dietary intake assessments.

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
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

  • Patients diagnosed with TB
  • Aged 18 years and above

排除标准

  • Pregnancy
  • Commencement of treatment ≥30 days prior to inclusion
  • Decreased kidney function
  • Missing informed consent
  • Mentally ill/disabled patients unable to comply with the treatment/intervention regimen

结局指标

主要结局

Anthropometry

时间窗: 6 months

Proportion of patients with BMI gain \>9% at end of treatment

次要结局

  • Treatment Outcome(6 months)
  • Anthropometry(2 years)
  • Treatment outcome(2 years)
  • Diet(6 months)
  • Health-related quality of life(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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