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

NCT07058233 | Completed

• 3 other identifiers: 25/UN2.F1/ETIK/PPM.00.02/2022Otsuka HoldingGlobal Fund to Fight AIDS, TB
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Drug-resistant tuberculosis; oral nutritional supplementation; malnutrition; total protein; globuline

Outcome Measures

Primary Outcomes (1)

• Body weight

  A change in body weight in kg

  Pre intervention and post intervention (at 60 days)

Secondary Outcomes (5)

• 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)

Study Arms (2)

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.

Dietary Supplement: Oral nutritional supplementation

Control group

NO INTERVENTION

standard treatment only

Interventions

Oral nutritional supplementation 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)

Intervention group

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RSUP Persahabatan: lead
• Otsuka Holdings Co., Ltd.: collaborator

Study Sites (1)

Rumah Sakit Umum Pusat Persahabatan

Jakarta, DKI Jakarta, 13230, Indonesia

Location

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant; Malnutrition

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Fathiyah Isbaniah Sp.P(K), Dr., dr.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: one group intervention (standard treatment + Oral Nutritional Supplementation) and one group placebo (standard treatment only)

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 10, 2025
• Study Start: April 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: July 10, 2025

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)