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Tuberculosis Multi Drug Resistant ActiveNCT07058233

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

A study testing Oral nutritional supplementation in people with Tuberculosis Multi Drug Resistant Active and Rifampin-Resistant Pulmonary Tuberculosis, run by RSUP Persahabatan at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 65 years
What is being tested?
Oral nutritional supplementation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteIndonesia
Study dates
1 Apr 2022to 30 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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,
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  • 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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Rumah Sakit Umum Pusat Persahabatan

    Jakarta, DKI Jakarta, 13230

Other trials in Indonesia

About this study

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).

Read the 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.

Being tested
Oral nutritional supplementation
Keywords
Drug-resistant tuberculosis, oral nutritional supplementation, malnutrition, total protein, globuline
Medical subject headings
Tuberculosis, Multidrug-Resistant, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral nutritional supplementationDietary 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)

Study groups in NCT07058233
Study groupRoleWhat they receive
Intervention groupExperimentalstandard 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.
Receives: Dietary Supplement: Oral nutritional supplementation
Control groupNo interventionstandard treatment only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body weight

    A change in body weight in kg

    Measured: Pre intervention and post intervention (at 60 days)

Secondary outcomes (5)

  1. Daily food intake

    Daily food intake of total energy, protein, fat, and carbohydrates. The subjects were given a form to record food intake 3 times a week (2 working days and 1 day off) for 8 weeks including the type and amount of food measured using standard units of spoons, glasses, etc. Furthermore, the intake data was converted into grams using a food ingredient analysis list and then analyzed using the 2007 nutrisurvey.

    Measured: From enrollment to 60 days after enrollment

  2. Albumin

    Serum albumin is measured by taking peripheral venous blood samples with units of g/dL.

    Measured: Pre intervention and post intervention (at 60 days)

  3. CRP

    CRP is measured by taking peripheral venous blood samples in mg/dL units.

    Measured: Pre intervention and post intervention (at 60 days)

  4. Total protein

    Total protein is measured using a peripheral venous blood sample in g/dL units.

    Measured: Pre intervention and post intervention (at 60 days)

  5. ESR

    Erythrocyte sedimentation rate is measured using a peripheral venous blood sample in mm/hour units.

    Measured: Pre intervention and post intervention (at 60 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2025
  2. Study start1 Apr 2022
  3. Primary completion30 Dec 2022
  4. Study completion30 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
one group intervention (standard treatment + Oral Nutritional Supplementation) and one group placebo (standard treatment only)
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07058233
Sponsor's protocol ID
25/UN2.F1/ETIK/PPM.00.02/2022
Other IDs
Otsuka Holding, Global Fund to Fight AIDS, TB
Status last verified
Dec 2022
First submitted
19 Jun 2025
Last updated
10 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Oral nutritional supplementation in people with Tuberculosis Multi Drug Resistant Active and Rifampin-Resistant Pulmonary Tuberculosis, run by RSUP Persahabatan at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body weight (time frame: Pre intervention and post intervention (at 60 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07058233.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.

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