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

NCT07058233 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-07-10

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

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)

Sponsors & Collaborators

  • Otsuka Holdings Co., Ltd.

    collaborator INDUSTRY

  • RSUP Persahabatan

    lead OTHER

Principal Investigators

  • Fathiyah Isbaniah Sp.P(K), Dr., dr. · Department of Pulmonology and Respiratory Medicine Faculty of Medicine, Universitas Indonesia, Persahabatan General Hospital, Jakarta

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2022-12-30
Completion
2022-12-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07058233 on ClinicalTrials.gov