The Impact of Malnutrition on Immune Responses to Tuberculosis

NCT05044910 | Active Not Recruiting DMC

• 1 other identifier: 2019037
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to assess immune responses to Mtb in children with MAM compared to well-nourished children and to evaluate the impact of a nutrition intervention on these immune responses.

Conditions

Malnutrition, Child; Tuberculosis

Keywords

malnutrition; moderate acute malnutrition; immunology

Outcome Measures

Primary Outcomes (1)

• IFNγ concentration

  IFNγ concentration in supernatant after overnight incubation of whole blood with TB antigens

  6 months

Study Arms (4)

MAM children with TB disease

Dietary Supplement: Ready to Use supplementary food (RUSF)

Wellnourished children with TB disease

MAM children with latent TB infection

Dietary Supplement: Ready to Use supplementary food (RUSF)

Well-nourished children with latent TB infection

Interventions

Ready to Use supplementary food (RUSF) DIETARY_SUPPLEMENT

Children with malnutrition will be given RUSF

MAM children with TB disease; MAM children with latent TB infection

Eligibility Criteria

• Age: 12 Months - 60 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

HIV negative, BCG vaccinated

You may qualify if:

• Age 12-60 months
• HIV-negative
• BCG vaccinated
• Moderate acute malnutrition (WHZ -2 to -3 or MUAC 115 - 125mm ± HAZ \<-2)
• TB disease
• Latent TB infection

You may not qualify if:

• Severe acute malnutrition (WHZ\<-3; MUAC\<115mm; bilateral oedema)
• Severe anaemia (Hb: \<7g/dl)
• Chronic infection (HIV, hepatitis B or C)
• Chronic disease (e.g. Crohn's disease)
• Feeding problems (eg cerebral palsy) that prevent ingestion of RUSF
• Known nut allergy
• MDR TB disease and contacts of MDR TB adults

Sponsors & Collaborators

• Tuberculosis Research Centre, India: lead
• Institute of Child Health, Madras Medical College, Chennai: collaborator
• Stanley Medical College: collaborator
• Kanchi Kamakoti Childs Trust Hospital, Chennai, India: collaborator
• Queen Mary University of London: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• DBT, India: collaborator

Study Sites (2)

Institute of Child Health

Chennai, Tamil Nadu, 600 008, India

Location

Government Stanley Medical College and Hospital

Chennai, Tamil Nadu, 600001, India

Location

Related Publications (1)

• Venkataraman A, Shanmugam S, Balaji S, Mani K, Shanmugavel AK, Muthuramalingam K, Hissar S, Thiruvengadam K, Selladurai E, Smuk M, Hanna LE, Prendergast AJ. Comparison of two mycobacterial strains in performance of the whole blood mycobacterial growth inhibition assay in Indian children. Tuberculosis (Edinb). 2022 Dec;137:102255. doi: 10.1016/j.tube.2022.102255. Epub 2022 Aug 31.

  PMID: 36252397 DERIVED

MeSH Terms

Conditions

Child Nutrition Disorders; Tuberculosis; Malnutrition

Condition Hierarchy (Ancestors)

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

Study Officials

• Aishwarya Venkataraman, MRCPCH

  ICMR-NIRT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 16, 2021
• Study Start: August 1, 2020
• Primary Completion: August 31, 2024
• Study Completion: December 1, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)