TuberculosisTB-LIONNCT03598842

Tuberculosis - Learning the Impact of Nutrition

A study testing Nutritional Supplementation Meal, Multivitamin and Anti-parasitic medications in people with Tuberculosis and Malnutrition, run by Boston Medical Center at 1 site in India.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Tuberculosis, Malnutrition, Helminth Infection
What is being tested?: Nutritional Supplementation Meal, Multivitamin and Anti-parasitic medications
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 786 participants
Where: 1 siteIndia
Study dates: 12 Jul 2019to 29 Dec 2025
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 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Household contact that has been housemate of eligible index case for at least the last month (See index case criteria below).
HIV seronegative
Willing to be tested for pregnancy if married
Age 18-60 years
Willingness by the patient to attend scheduled follow-up visits and undergo study assessments
Able to provide informed consent

Show all 12Show fewer

Intervention inclusion: On average, one meal consumed at home per day.
Sputum Ziehl-Neelsen stain positive for acid-fast bacillus (AFB) ≥1+
Culture or Xpert positive for Mtb; those who are smear+ but ultimately Xpert or culture negative, will be included until their culture results return at which time they will retrospectively be removed from the study.
No history of TB treatment (i.e., no history of partial or complete treatment for a previous TB episode)
Has at least 1 household contact with whom they have shared a house during the previous one month
Agrees to have household contact notified about study

Who cannot join

In the team's judgement, individual is not expected to survive for 12 months
HIV infection or not willing to undergo HIV testing (if no documented HIV test)
Pregnant at enrollment
Known diabetes mellitus or evidence of diabetes on hemoglobin A1C (HA1C)
Xpert positive among those able to produce sputum
TB symptoms (night sweats, weight loss, cough) - Only if sputum positive

Show all 18Show fewer

Any history of TB disease during their lifetime
We will retrospectively exclude household contacts of presumed TB cases whose cultures do not confirm Mtb or who are Xpert negative.
Evidence of kwashiorkor (pitting edema of foot or lower leg) those with BMI <16
Abnormal K, Mg, Phos in those with BMI <16
Pregnant at enrollment
No Xpert or culture confirmation and unable to provide sputum sample
No household contacts who share room
Known Multidrug-resistant tuberculosis (MDR-TB) or extensively drug-resistant tuberculosis (XDR-TB) case
BMI <14 kg/m2
Abnormal K, Mg, Phos in those with BMI 14 - 16
Lower extremity edema/kwashiorkor those with BMI 14-16
Reported neuropathy in lower extremities (may result from thiamine deficiency)

Trial locations and contacts

1 site in 1 country.

India1 site

Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry, Tamil Nadu

Other trials in India

About this study

Official title: Tuberculosis- Learning the Impact of Nutrition

The proposed work is based on the finding that one-third of the world is infected with the bacteria Mycobacterium tuberculosis (Mtb) and only 10% of these individuals develop TB. The study aims to identify factors that drive progression to disease and study signals (markers of the immune response) that detect who will progress to active TB and why this happens. Armed with these markers, the study will address how malnutrition and worms alter this signal profile to cause active TB. The work will be conducted in India, where there are 2.8 million TB cases each year - more than any other country - and where the government has committed to eliminating TB by 2035. Data suggest that malnutrition and parasites increase risk of TB disease so the investigators will feed malnourished household contacts and have those with parasites receive medication to treat these. Using this infrastructure, the investigators will evaluate the immunologic impact of feeding on TB pathogenesis. An additional aim is to understand the role of parasitic worms with the goal of determining the utility of low-cost ($.02 per dose) worm treatment as part of TB control efforts. Risk of developing TB will be evaluated for 120 household contacts of TB patients in the setting of their malnutrition and parasites. There are four study arms comprised of thirty participants each -- malnourished with parasite infection, malnourished with no parasite infection, well-nourished with parasite infection, and well-nourished with no parasite infection. Correlates of risk of disease will be assessed using blood messenger RNA/micro RNA (mRNA/miRNA) sequencing and T cell immune markers. The TB LION study will confirm that malnutrition and worms increase the risk of active TB and will provide the basis for effective interventions that could change the face of the TB pandemic and have a profound impact on the health of people worldwide. Participants in this study will be household contacts of tuberculosis index cases. The index cases in this study do not participate in the study once a household contact is established. All interventions and follow up are only being conducted within the household contact cohort. All intervention supplies, treatments, and biologics will be purchased internationally.

Conditions: Tuberculosis, Malnutrition, Helminth Infection
Being tested: Nutritional Supplementation Meal, Multivitamin, Anti-parasitic medications
Keywords: blood signature of Tb risk, anti Mtb immunity, RNA biomarkers, RePORT Study, India
Medical subject headings: Tuberculosis, Malnutrition, Trematode Infections

What participants receive

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

Nutritional Supplementation MealDietary supplement
Study participants will be given a nutritional supplementation for 6 months. The supplementation consists of a vegan meal plan.
MultivitaminDietary supplement
Study participants will be given a daily multivitamin to take for 6 months.
Anti-parasitic medicationsDrug
Also called albendazole, ivermectin, metronidazole
Study participants will be given anti-parasitic medications per Indian guidelines such as albendazole, ivermectin, metronidazole, or other medications to treat their parasitic infection.

Study groups in NCT03598842
Study group	Role	What they receive
Malnourished without lung parasites	Experimental	Thirty study participants, household contacts of an index TB case, who are malnourished and do not have lung parasites will be consented into the study intervention. The household contact and the rest of the household members will receive nutritional supplementation meals for six months. The family will receive the food in biweekly installments and will be given a vegan meal plan.The consented household contact will also receive a daily multivitamin. Receives: Dietary Supplement: Nutritional Supplementation Meal; Dietary Supplement: Multivitamin
Malnourished with lung parasites	Experimental	Thirty study participants, household contacts of an index TB case, who are malnourished and have lung parasites will be consented into the study intervention. The household contact and the rest of the household members will receive nutritional supplementation meals for six months. The family will receive the food in biweekly installments and will be given a vegan meal plan. The consented household contact will also receive a daily multivitamin. These thirty study participants will be given anti-parasitic medications such as albendazole, ivermectin, metronidazole, or other medication per Indian guidelines to treat the parasite infection. Receives: Dietary Supplement: Nutritional Supplementation Meal; Dietary Supplement: Multivitamin; Drug: Anti-parasitic medications
Well-nourished with lung parasites	Active comparator	These thirty study participants will be given anti-parasitic medications such as albendazole, ivermectin, metronidazole, or other medication per Indian guidelines to treat the parasite infection. Receives: Drug: Anti-parasitic medications
Well-nourished without lung parasites	No intervention	These thirty study participants will serve as the control.These participants will be well-nourished and not have a parasite infection; therefore, they will not receive the nutritional supplementation or treatment for parasite infection.

What is being measured

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

Immune response
Interferon Gamma-peripheral blood mononuclear cell (PBMC) from malnourished and well-nourished household contacts (HHC) will be labeled with carboxyfluorescein succinimidyl ester (CFSE) and then stimulated with early secreted antigen target-6 (ESAT-6) and culture filtrate protein-10 (CFP-10) peptide libraries. After 72 hours, supernatants will be harvested and the cells analyzed by flow cytometry to monitor proliferating cells. As CFSE concentrations in a cell are halved with every cell division, each generation of cells appears as a distinct peak on the flow cytometry histogram providing a proliferative index. Supernatants will be evaluated by multiplex ELISA.
Measured: Visit 1
Immune response
Interferon Gamma - PBMC from malnourished and well-nourished HHC will be labeled with carboxyfluorescein succinimidyl ester (CFSE) and then stimulated with ESAT-6 and CFP-10 peptide libraries. After 72 hours, supernatants will be harvested and the cells analyzed by flow cytometry to monitor proliferating cells. As CFSE concentrations in a cell are halved with every cell division, each generation of cells appears as a distinct peak on the flow cytometry histogram providing a proliferative index. Supernatants will be evaluated by multiplex ELISA.
Measured: Visit 2 (approximately 7 days after visit 1)
Immune response
Interferon Gamma - PBMC from malnourished and well-nourished HHC will be labeled with carboxyfluorescein succinimidyl ester (CFSE) and then stimulated with ESAT-6 and CFP-10 peptide libraries. After 72 hours, supernatants will be harvested and the cells analyzed by flow cytometry to monitor proliferating cells. As CFSE concentrations in a cell are halved with every cell division, each generation of cells appears as a distinct peak on the flow cytometry histogram providing a proliferative index. Supernatants will be evaluated by multiplex ELISA.
Measured: Visit 5 (3 months after parasite treatment / intervention initiation)
Immune Response
Interferon Gamma - PBMC from malnourished and well-nourished HHC will be labeled with carboxyfluorescein succinimidyl ester (CFSE) and then stimulated with ESAT-6 and CFP-10 peptide libraries. After 72 hours, supernatants will be harvested and the cells analyzed by flow cytometry to monitor proliferating cells. As CFSE concentrations in a cell are halved with every cell division, each generation of cells appears as a distinct peak on the flow cytometry histogram providing a proliferative index. Supernatants will be evaluated by multiplex ELISA.
Measured: Visit 6 (6 months after parasite treatment / intervention initiation)
Immune Response
Interferon Gamma - PBMC from malnourished and well-nourished HHC will be labeled with carboxyfluorescein succinimidyl ester (CFSE) and then stimulated with ESAT-6 and CFP-10 peptide libraries. After 72 hours, supernatants will be harvested and the cells analyzed by flow cytometry to monitor proliferating cells. As CFSE concentrations in a cell are halved with every cell division, each generation of cells appears as a distinct peak on the flow cytometry histogram providing a proliferative index. Supernatants will be evaluated by multiplex ELISA.
Measured: Visit 7 (12 months after parasite treatment / intervention initiation)

Secondary outcomes (6)

Anthropometric measurement
Body Mass Index - (BMI; weight/height in kg/m2). Measurements will be taken in triplicate. Height will be measured to the nearest 0.5 cm with a stadiometer (or knee height, ulnar length or arm span [demispan] for those persons unable to stand fully erect); body weight will be measured to the nearest 0.1 kg.
Measured: Visit 1
Anthropometric measurement
Body Mass Index - (BMI; weight/height in kg/m2). Measurements will be taken in triplicate. Height will be measured to the nearest 0.5 cm with a stadiometer (or knee height, ulnar length or arm span [demispan] for those persons unable to stand fully erect); body weight will be measured to the nearest 0.1 kg.
Measured: Visit 5 (3 months after parasite treatment / intervention initiation)
Anthropometric measurement
Body Mass Index - (BMI; weight/height in kg/m2). Measurements will be taken in triplicate. Height will be measured to the nearest 0.5 cm with a stadiometer (or knee height, ulnar length or arm span [demispan] for those persons unable to stand fully erect); body weight will be measured to the nearest 0.1 kg.
Measured: Visit 6 (6 months after parasite treatment / intervention initiation)
Anthropometric measurements
Body Mass Index - (BMI; weight/height in kg/m2). Measurements will be taken in triplicate. Height will be measured to the nearest 0.5 cm with a stadiometer (or knee height, ulnar length or arm span [demispan] for those persons unable to stand fully erect); body weight will be measured to the nearest 0.1 kg.
Measured: Visit 7 (12 months after parasite treatment / intervention initiation)
Anthropometric measurements
Body Mass Index - (BMI; weight/height in kg/m2). Measurements will be taken in triplicate. Height will be measured to the nearest 0.5 cm with a stadiometer (or knee height, ulnar length or arm span [demispan] for those persons unable to stand fully erect); body weight will be measured to the nearest 0.1 kg.
Measured: Visit 8 (18 months after parasite treatment / intervention initiation)
Anthropometric measurements
Body Mass Index - (BMI; weight/height in kg/m2). Measurements will be taken in triplicate. Height will be measured to the nearest 0.5 cm with a stadiometer (or knee height, ulnar length or arm span [demispan] for those persons unable to stand fully erect); body weight will be measured to the nearest 0.1 kg.
Measured: Visit 9 (24 months after parasite treatment / intervention initiation)

Timeline

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

12 Jul 201929 Dec 2025

First posted26 Jul 2018
Study start12 Jul 2019
Primary completion29 Dec 2025
Study completion29 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for TuberculosisStudies of the same condition, open and under way.
More trials run by Boston Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 786 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03598842
Sponsor's protocol ID: H-37473
Other IDs: 6005415
Acronym: TB-LION
Status last verified: Jan 2026
First submitted: 16 Jul 2018
Last updated: 12 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Locks LM, Kaipilyawar V, Jain K, VanValkenburg A, Karoly M, Dauphinais MR, Cintron C, Babu SP, Maloomian K, Verma S, Joseph NM, Sarkar S, Rajkumari N, Johnson WE, Horsburgh CR Jr, Ellner JJ, Salgame P, Hochberg NS, Lakshminarayanan S, Narasimhan PB, Sinha P. Attenuated Mycobacterium tuberculosis-specific Th1 cytokine responses in household contacts with undernutrition and their partial reconstitution during six months of nutritional support. J Infect Dis. 2026 Sep 8:jiag464. doi: 10.1093/infdis/jiag464. Online ahead of print.
PubMed 42708885
Cintron C, Narasimhan PB, Locks L, Babu S, Sinha P, Rajkumari N, Kaipilyawar V, Bhargava A, Maloomian K, Chandrasekaran P, Verma S, Joseph N, Johnson WE, Wanke C, Horsburgh CR Jr, Ellner JJ, Sarkar S, Salgame P, Lakshminarayanan S, Hochberg NS. Tuberculosis-Learning the Impact of Nutrition (TB LION): protocol for an interventional study to decrease TB risk in household contacts. BMC Infect Dis. 2021 Oct 12;21(1):1058. doi: 10.1186/s12879-021-06734-z.
PubMed 34641820

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tuberculosis- Learning the Impact of Nutrition
ClinicalTrials.gov ID: NCT03598842
Acronym / sponsor ID: TB-LION / H-37473
Conditions: Tuberculosis, Malnutrition, Helminth Infection
Keywords: blood signature of Tb risk, anti Mtb immunity, RNA biomarkers, RePORT Study, India
Study type: Interventional
Recruitment status: Completed
Enrolment: 786 participants (actual)
Lead sponsor: Boston Medical CenterUniversity, hospital or other
Collaborators: Rutgers, The State University of New Jersey, Jawaharlal Institute of Postgraduate Medical Education & Research
Study start: 12 Jul 2019 (actual)
Primary completion: 29 Dec 2025 (actual)
Study completion: 29 Dec 2025 (actual)
First posted: 26 Jul 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Malnourished without lung parasites	Experimental	Dietary Supplement: Nutritional Supplementation Meal, Dietary Supplement: MultivitaminThirty study participants, household contacts of an index TB case, who are malnourished and do not have lung parasites will be consented into the study intervention. The household contact and the rest of the household members will receive nutritional supplementation meals for six months. The family will receive the food in biweekly installments and will be given a vegan meal plan.The consented household contact will also receive a daily multivitamin.
Malnourished with lung parasites	Experimental	Dietary Supplement: Nutritional Supplementation Meal, Dietary Supplement: Multivitamin, Drug: Anti-parasitic medicationsThirty study participants, household contacts of an index TB case, who are malnourished and have lung parasites will be consented into the study intervention. The household contact and the rest of the household members will receive nutritional supplementation meals for six months. The family will receive the food in biweekly installments and will be given a vegan meal plan. The consented household contact will also receive a daily multivitamin. These thirty study participants will be given anti-parasitic medications such as albendazole, ivermectin, metronidazole, or other medication per Indian guidelines to treat the parasite infection.
Well-nourished with lung parasites	Active comparator	Drug: Anti-parasitic medicationsThese thirty study participants will be given anti-parasitic medications such as albendazole, ivermectin, metronidazole, or other medication per Indian guidelines to treat the parasite infection.
Well-nourished without lung parasites	No intervention	–These thirty study participants will serve as the control.These participants will be well-nourished and not have a parasite infection; therefore, they will not receive the nutritional supplementation or treatment for parasite infection.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Household contact that has been housemate of eligible index case for at least the last month (See index case criteria below).
HIV seronegative
Willing to be tested for pregnancy if married
Age 18-60 years
Willingness by the patient to attend scheduled follow-up visits and undergo study assessments

Key exclusion criteria (18 listed)

In the team's judgement, individual is not expected to survive for 12 months
HIV infection or not willing to undergo HIV testing (if no documented HIV test)
Pregnant at enrollment
Known diabetes mellitus or evidence of diabetes on hemoglobin A1C (HA1C)
Xpert positive among those able to produce sputum

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nutritional Supplementation MealStudy participants will be given a nutritional supplementation for 6 months. The supplementation consists of a vegan meal plan.	Dietary supplement	Malnourished with lung parasites, Malnourished without lung parasites
MultivitaminStudy participants will be given a daily multivitamin to take for 6 months.	Dietary supplement	Malnourished with lung parasites, Malnourished without lung parasites
Anti-parasitic medicationsAlso: albendazole, ivermectin, metronidazoleStudy participants will be given anti-parasitic medications per Indian guidelines such as albendazole, ivermectin, metronidazole, or other medications to treat their parasitic infection.	Drug	Malnourished with lung parasites, Well-nourished with lung parasites

Primary outcome

Immune response
Time frame: Visit 1
Interferon Gamma-peripheral blood mononuclear cell (PBMC) from malnourished and well-nourished household contacts (HHC) will be labeled with carboxyfluorescein succinimidyl ester (CFSE) and then stimulated with early secreted antigen target-6 (ESAT-6) and culture filtrate protein-10 (CFP-10) peptide libraries. After 72 hours, supernatants will be harvested and the cells analyzed by flow cytometry to monitor proliferating cells. As CFSE concentrations in a cell are halved with every cell division, each generation of cells appears as a distinct peak on the flow cytometry histogram providing a proliferative index. Supernatants will be evaluated by multiplex ELISA.
Immune response
Time frame: Visit 2 (approximately 7 days after visit 1)
Interferon Gamma - PBMC from malnourished and well-nourished HHC will be labeled with carboxyfluorescein succinimidyl ester (CFSE) and then stimulated with ESAT-6 and CFP-10 peptide libraries. After 72 hours, supernatants will be harvested and the cells analyzed by flow cytometry to monitor proliferating cells. As CFSE concentrations in a cell are halved with every cell division, each generation of cells appears as a distinct peak on the flow cytometry histogram providing a proliferative index. Supernatants will be evaluated by multiplex ELISA.
Immune response
Time frame: Visit 5 (3 months after parasite treatment / intervention initiation)
Interferon Gamma - PBMC from malnourished and well-nourished HHC will be labeled with carboxyfluorescein succinimidyl ester (CFSE) and then stimulated with ESAT-6 and CFP-10 peptide libraries. After 72 hours, supernatants will be harvested and the cells analyzed by flow cytometry to monitor proliferating cells. As CFSE concentrations in a cell are halved with every cell division, each generation of cells appears as a distinct peak on the flow cytometry histogram providing a proliferative index. Supernatants will be evaluated by multiplex ELISA.
Immune Response
Time frame: Visit 6 (6 months after parasite treatment / intervention initiation)
Interferon Gamma - PBMC from malnourished and well-nourished HHC will be labeled with carboxyfluorescein succinimidyl ester (CFSE) and then stimulated with ESAT-6 and CFP-10 peptide libraries. After 72 hours, supernatants will be harvested and the cells analyzed by flow cytometry to monitor proliferating cells. As CFSE concentrations in a cell are halved with every cell division, each generation of cells appears as a distinct peak on the flow cytometry histogram providing a proliferative index. Supernatants will be evaluated by multiplex ELISA.
Immune Response
Time frame: Visit 7 (12 months after parasite treatment / intervention initiation)
Interferon Gamma - PBMC from malnourished and well-nourished HHC will be labeled with carboxyfluorescein succinimidyl ester (CFSE) and then stimulated with ESAT-6 and CFP-10 peptide libraries. After 72 hours, supernatants will be harvested and the cells analyzed by flow cytometry to monitor proliferating cells. As CFSE concentrations in a cell are halved with every cell division, each generation of cells appears as a distinct peak on the flow cytometry histogram providing a proliferative index. Supernatants will be evaluated by multiplex ELISA.

6 secondary outcomes

Anthropometric measurement
Time frame: Visit 1
Anthropometric measurement
Time frame: Visit 5 (3 months after parasite treatment / intervention initiation)
Anthropometric measurement
Time frame: Visit 6 (6 months after parasite treatment / intervention initiation)
Anthropometric measurements
Time frame: Visit 7 (12 months after parasite treatment / intervention initiation)
Anthropometric measurements
Time frame: Visit 8 (18 months after parasite treatment / intervention initiation)
Anthropometric measurements
Time frame: Visit 9 (24 months after parasite treatment / intervention initiation)

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
Derived from this study: PubMed 42708885Locks LM, Kaipilyawar V, Jain K, VanValkenburg A, Karoly M, Dauphinais MR, Cintron C, Babu SP, Maloomian K, Verma S, Joseph NM, Sarkar S, Rajkumari N, Johnson WE, Horsburgh CR Jr, Ellner JJ, Salgame P, Hochberg NS, Lakshminarayanan S, Narasimhan PB, Sinha P. Attenuated Mycobacterium tuberculosis-specific Th1 cytokine responses in household contacts with undernutrition and their partial reconstitution during six months of nutritional support. J Infect Dis. 2026 Sep 8:jiag464. doi: 10.1093/infdis/jiag464. Online ahead of print.
Derived from this study: PubMed 34641820Cintron C, Narasimhan PB, Locks L, Babu S, Sinha P, Rajkumari N, Kaipilyawar V, Bhargava A, Maloomian K, Chandrasekaran P, Verma S, Joseph N, Johnson WE, Wanke C, Horsburgh CR Jr, Ellner JJ, Sarkar S, Salgame P, Lakshminarayanan S, Hochberg NS. Tuberculosis-Learning the Impact of Nutrition (TB LION): protocol for an interventional study to decrease TB risk in household contacts. BMC Infect Dis. 2021 Oct 12;21(1):1058. doi: 10.1186/s12879-021-06734-z.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pranay Sinha, MD principal investigator

Boston University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional Supplementation Meal, Multivitamin and Anti-parasitic medications in people with Tuberculosis and Malnutrition, run by Boston Medical Center at 1 site in India.

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 12 inclusion and 18 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 12 Jan 2026. 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 India. 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?

Immune response (time frame: Visit 1). The study lists 5 primary outcomes in all. 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 NCT03598842, which also lists 2 linked publications.

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 12 Jan 2026.