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