跳至主要内容
临床试验/NCT07058233
NCT07058233已完成不适用

Oral Nutritional Supplementation and Weight Changes During Therapy in Malnourished Patients With Resistant Tuberculosis: A Clinical Trial

RSUP Persahabatan1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年4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
发起方
入组人数
70
试验地点
1
主要终点
Body weight

研究概览

简要总结

Tuberculosis increases energy demands and protein breakdown, leading to muscle wasting. Malnutrition and minimal weight gain less than 5% in first two months predict treatment failure. Malnutrition is defined as weight loss more than 5% in three months and Body Mass Index (BMI) ≤ 20 kg/m². This study assesses weight changes with high-energy, high-protein oral nutritional supplementation (ONS).

详细描述

Tuberculosis (TB) is linked to poverty, malnutrition, and reduced immunity, with malnutrition both contributing to and resulting from TB.1-3 Active TB increases energy needs, causes protein breakdown, and leads to muscle wasting. Malnutrition, which is common in TB patients, worsens clinical outcomes and increases the risk of death.1 TB treatments can also cause nausea and vomiting, further contributing to malnutrition.4 Thus integrated management is essential for successful treatment.

In India, 68.6% of MDR-TB patients without HIV infection are malnourished, a prevalence comparable to that observed among MDR-TB patients at Persahabatan General Hospital, Jakarta, Indonesia (51.8%).5,6 Malnourished MDR TB patients have worse clinical outcomes, more side effects, and a higher risk of death.7 A BMI under 18.5 kg/m2 and inadequate weight gain during treatment indicate a poor response and increased risk of recurrence.1 Failure to gain weight (≤ 5%) in the first two months of treatment has been demonstrated to be linked to TB recurrence.8 Oral nutritional supplements have demonstrated the potential to improve nutritional status, muscle strength, and immunity, thus potentially facilitating an accelerated treatment process. Studies have also shown that nutritional supplements can improve BMI and gamma interferon levels.9 However, some studies have indicated that despite increased macronutrient intake, MDR TB patients may still experience a decline in body weight.10 This study aims to evaluate whether oral nutritional supplements providing 705 kcal and 30.5 grams of protein daily during the first two months can increase body weight and improve other clinical outcomes of MDR TB patients, including the impact of supplementation on albumin, globulin, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) levels.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
15 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Who had access to electronic devices (e.g., mobile phones) for adherence monitoring
  • •individuals newly diagnosed with rifampicin-resistant pulmonary tuberculosis (RR-TB), multidrug-resistant tuberculosis (MDR-TB), or pre-extensively drug-resistant tuberculosis (Pre-XDR-TB) at the drug-resistant tuberculosis outpatient clinic of Persahabatan General Hospital, Jakarta, Indonesia.
  • •BMI of 13-20 kg/m²
  • •had received standardized or individualized treatment regimens for seven days
  • •had no severe drug-induced hepatitis indicated by elevated liver enzymes >5 times the normal upper limit

排除标准

  • •individuals with HIV infection,
  • •end-stage renal failure,
  • •severe anemia (hemoglobin <8 g/dL),
  • •severe hypoalbuminemia (albumin <2.5 g/dL),
  • •acute or chronic liver diseases (including hepatitis, cirrhosis, or jaundice),
  • •interstitial lung disease (ILD),
  • •anatomical gastrointestinal disorders (either congenital or post-surgical),
  • •diabetes mellitus,
  • •long-term corticosteroid or immunosuppressant therapy
  • •other acute pulmonary infections such as pneumonia,
  • •exacerbations of chronic obstructive pulmonary disease (COPD), or asthma

研究组 & 干预措施

Intervention group

Experimental

standard Oral Nutritional Supplement (ONS) in the form of a soy-based drink (235 kcal/200mL: 10.34 g protein, 7.9 g fat, 30.61 g carbohydrate; Protein; Otsuka) with the instruction to consume three (3) sachets per day (total of 705 kcal and 31 grams of protein) plus standard treatment.

干预措施: Oral nutritional supplementation (Dietary Supplement)

Control group

No Intervention

standard treatment only

结局指标

主要结局

Body weight

时间窗: Pre intervention and post intervention (at 60 days)

A change in body weight in kg

次要结局

  • Daily food intake(From enrollment to 60 days after enrollment)
  • Albumin(Pre intervention and post intervention (at 60 days))
  • CRP(Pre intervention and post intervention (at 60 days))
  • Total protein(Pre intervention and post intervention (at 60 days))
  • ESR(Pre intervention and post intervention (at 60 days))

研究者

发起方
RSUP Persahabatan
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验