Tuberculosis Clinical Trial
Official title:
The Effects of Tuberculosis on Dietary Iron Absorption and Systemic Iron Utilization: a Double Stable Isotope Study in Bagamoyo, Tanzania
Background: The disease burden of tuberculosis (TB), second only to HIV/AIDS among
infectious diseases, is a major public health problem in developing countries. Accumulating
evidence suggests that iron status is a primary determinant of TB progression. Anaemia is
prevalent in patients with TB, particularly in sub-Saharan Africa, and associated with
increased mortality. Anaemia in TB may be due to inflammation, dietary iron deficiency, or
both, and distinguishing among these aetiologies is difficult. Iron supplementation is
commonly used to treat anaemia in TB patients, but may be unnecessary if inflammation is the
cause. Body iron sequestered by TB inflammation can be mobilized during treatment and used
to correct the anaemia. Moreover, supplemental iron may be retained within macrophages,
potentially increasing susceptibility to TB and leading to a poorer clinical outcome. Thus,
better understanding of iron metabolism during TB and the aetiology of TB-related anaemia
would clarify the potential role of iron in pathogenesis and optimal management of the
disease.
The investigators hypothesize that: a) TB will increase circulating hepcidin and thereby
impair dietary iron absorption and systemic utilization of iron, resulting in iron
sequestration and anaemia; b) TB treatment and resolution of inflammation over 6 months will
decrease circulating hepcidin, correcting these impairments and improving iron status and
hemoglobin; c) the majority of iron utilized to replenish hemoglobin during recovery from TB
will come from mobilization of sequestered iron stores rather than from iron absorption.
Objectives: Use iron stable isotopes to characterize iron balance over six months of TB
treatment, and specifically to: a) quantify oral and intravenous iron incorporation (oral
absorption and systemic iron utilization) at three time points during TB treatment (acute
disease, after the intensive treatment phase and at completion of the continuation treatment
phase); and b) determine the effect of treatment on iron mobilization from stores to
replenish hemoglobin.
Methods/Subjects: Using a triple stable-isotope technique, iron absorption from labelled
test meals (57Fe) and systemic iron utilization after labelled intravenous doses (54Fe,
58Fe) will be determined in 18 Tanzanian subjects with newly diagnosed pulmonary TB. The
subjects will be studied at three time points (i) the day after TB diagnosis while infected,
(ii) after 8 weeks of intensive phase treatment, and (iii) after another 16 weeks of
continuation phase treatment. Iron status, hemoglobin, hepcidin and inflammation indexes
will be measured at each time point. Isotope enrichment during the two treatment phases will
be measured to estimate the relative rates of iron absorption and mobilization from stores
during the intensive and continuation phases to determine the relative contributions of iron
absorption and iron mobilization from stores during TB treatment and recovery.
Outcome: These studies will provide important new insights into the aetiology of anaemia and
iron metabolism in TB patients. The results will provide essential data for evidence-based
recommendations on the timing, administration route and efficacy of iron therapy in patients
with TB, making possible, a safer and more effective treatment of anaemia in TB while
decreasing morbidity and mortality from the disease.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05738681 -
Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial
|
Phase 2/Phase 3 | |
Recruiting |
NCT05526885 -
Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa
|
N/A | |
Completed |
NCT04369326 -
Community Initiated Preventive Therapy for TB
|
N/A | |
Recruiting |
NCT04568967 -
TB-CAPT EXULTANT - HIV
|
N/A | |
Completed |
NCT02337270 -
Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol
|
Phase 1 | |
Not yet recruiting |
NCT06253715 -
Shortened Regimen for Drug-susceptible TB in Children
|
Phase 3 | |
Recruiting |
NCT04271397 -
Immunological Biomarkers in Tuberculosis Management
|
N/A | |
Withdrawn |
NCT03639038 -
Tuberculosis Diagnosis by Flow Cytometry
|
||
Completed |
NCT03199313 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
|
Phase 1 | |
Recruiting |
NCT04975178 -
Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
|
Phase 3 | |
Completed |
NCT04463680 -
Rifampin and the Contraceptive Implant
|
Phase 4 | |
Completed |
NCT03973970 -
Assessing the Ability of the T-SPOT®.TB Test (IQ)
|
||
Recruiting |
NCT04230395 -
Alcohol Reduction Among People With TB and HIV in India
|
N/A | |
Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
Active, not recruiting |
NCT02906007 -
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05917210 -
Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
|
N/A | |
Not yet recruiting |
NCT06017843 -
Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding
|
N/A | |
Not yet recruiting |
NCT05845112 -
Start Taking Action For TB Diagnosis
|
||
Active, not recruiting |
NCT02715271 -
Study of TB Lesions Obtained in Therapeutical Surgery
|
||
Completed |
NCT02781909 -
Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis
|
Phase 2 |