drugset / Trial / NCT02554318
Fermented Soybean Supplementation Among Active Pulmonary Tuberculosis Patients With Standard Therapy in Indonesia
Completed
147 enrolled
University of Giessen
Indonesian Directorate General of Higher Education · collab
RandomizedParallel-groupOpen-labelSupportive care
Summary
Tuberculosis (TB) patients often have a lower body mass index (BMI) and experience wasting. Wasting reduces lean body mass and may cause physical function impairment. This study aimed to determine the efficacy of fermented soybeans (tempeh) as a food supplement on body weight and physical function changes among active pulmonary tuberculosis patients with standard therapy.
Timeline
- Start
- 2013-11
- Primary completion
- 2015-02
- Completion
- 2015-02
Publications
- Background Paton NI, Chua YK, Earnest A, Chee CB. Randomized controlled trial of nutritional supplementation in patients with newly diagnosed tuberculosis and wasting. Am J Clin Nutr. 2004 Aug;80(2):460-5. doi: 10.1093/ajcn/80.2.460.
- Background Martins N, Morris P, Kelly PM. Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste. BMJ. 2009 Oct 26;339:b4248. doi: 10.1136/bmj.b4248.
- Background Jahnavi G, Sudha CH. Randomised controlled trial of food supplements in patients with newly diagnosed tuberculosis and wasting. Singapore Med J. 2010 Dec;51(12):957-62.
- Background PrayGod G, Range N, Faurholt-Jepsen D, Jeremiah K, Faurholt-Jepsen M, Aabye MG, Jensen L, Jensen AV, Grewal HM, Magnussen P, Changalucha J, Andersen AB, Friis H. The effect of energy-protein supplementation on weight, body composition and handgrip strength among pulmonary tuberculosis HIV-co-infected patients: randomised controlled trial in Mwanza, Tanzania. Br J Nutr. 2012 Jan;107(2):263-71. doi: 10.1017/S0007114511002832. Epub 2011 Jul 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Ethambutol | Small molecule | 550 mg | Oral |
| Background | Ethambutol | Small molecule | 825 mg | Oral |
| Background | Ethambutol | Small molecule | 1100 mg | Oral |
| Background | Ethambutol | Small molecule | 1375 mg | Oral |
| Background | Isoniazid | Small molecule | 150 mg | Oral |
| Background | Isoniazid | Small molecule | 225 mg | Oral |
| Background | Isoniazid | Small molecule | 300 mg | Oral |
| Background | Isoniazid | Small molecule | 375 mg | Oral |
| Background | Pyrazinamide | Small molecule | 800 mg | Oral |
| Background | Pyrazinamide | Small molecule | 1200 mg | Oral |
| Background | Pyrazinamide | Small molecule | 1600 mg | Oral |
| Background | Pyrazinamide | Small molecule | 2000 mg | Oral |
| Background | Rifampin | Small molecule | 300 mg | Oral |
| Background | Rifampin | Small molecule | 450 mg | Oral |
| Background | Rifampin | Small molecule | 600 mg | Oral |
| Background | Rifampin | Small molecule | 750 mg | Oral |