HIV/AIDS Tuberculosis
Conditions
Interventions
Carotenoid rich food supplementation
None
Standard of care
Sponsors
Baylor College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of TB (within 1 month of TB diagnosis) Adults aged 18 to 65 years Ability to provide written informed consent Participants should have no severe comorbid conditions Willingness to adhere to the study schedule for skin carotenoid assessments, blood sample collections, and follow-up visits. Participants must be newly diagnosed and have started standard TB treatment within the last 30 days. Absence of significant skin conditions, lesions, or infections that could interfere with accurate measurement of cutaneous carotenoids. Absence of conditions that may interfere with study outcomes, such as known genetic disorders affecting carotenoid metabolism, or severe chronic diseases that could impact inflammation independently of TB
Exclusion criteria
Exclusion criteria: Pregnancy or Lactation Severe comorbid conditions Significant skin conditions Chronic inflammatory or autoimmune diseases Recent use of certain medications that could significantly impact carotenoid levels or inflammatory markers, such as high-dose antioxidants or immunosuppressive drugs. Participation in another clinical trial within the past 30 days that could interfere with the study outcomes or introduce additional variables. Inability or unwillingness to comply with study procedures, including regular visits for carotenoid assessments, blood sample collections, or adherence to dietary and lifestyle recommendations if applicable. Current heavy substance abuse (e.g alcohol, smoking, recreational drugs) that could interfere with study participation or outcomes. Severe psychiatric or mental health conditions that might impair the participant’s ability to provide informed consent or adhere to the study protocol. Presence of conditions that may interfere with study outcomes, such as known genetic disorders affecting carotenoid metabolism, or severe chronic diseases that could impact inflammation independently of TB (e.g., cancer, autoimmune diseases). Skin carotenoid levels above 500 units.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cutaneous carotenoid levels from baseline to the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in systemic inflammatory markers;TB-related clinical outcomes;Changes in the participants overall nutritional status | — |
Countries
Swaziland
Contacts
Public ContactNondumiso Dube
Baylor Foundation Eswatini
Outcome results
None listed