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

NCT ID: NCT07058233

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-12-30

Brief Summary

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).

Detailed Description

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.

Conditions

Tuberculosis Multi Drug Resistant Active; Rifampin-Resistant Pulmonary Tuberculosis; Pre-xdr tb

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Oral nutritional supplementation

Intervention Type: DIETARY_SUPPLEMENT

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)

Control group

standard treatment only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Oral nutritional supplementation

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)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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),
• cancer,
• 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Holdings Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

RSUP Persahabatan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fathiyah Isbaniah Sp.P(K), Dr., dr.

Role: STUDY_CHAIR

Department of Pulmonology and Respiratory Medicine Faculty of Medicine, Universitas Indonesia, Persahabatan General Hospital, Jakarta

Locations

Rumah Sakit Umum Pusat Persahabatan

Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

Otsuka Holding

Identifier Type: OTHER

Identifier Source: secondary_id

Global Fund to Fight AIDS, TB

Identifier Type: OTHER

Identifier Source: secondary_id

25/UN2.F1/ETIK/PPM.00.02/2022

Identifier Type: -

Identifier Source: org_study_id