Iron Absorption and Utilization During Tuberculosis and After Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02176772
• Date of registration: 23/06/2014
• Prospective Registration: Yes
• Primary sponsor: Swiss Federal Institute of Technology
• Public title: Iron Absorption and Utilization During Tuberculosis and After Treatment
• Scientific title: The Effects of Tuberculosis on Dietary Iron Absorption and Systemic Iron Utilization: a Double Stable Isotope Study in Bagamoyo, Tanzania
• Date of first enrolment: April 2015
• Target sample size: 19
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02176772
• Study type: Observational
• Phase: N/A

Countries of recruitment

Tanzania

Key inclusion & exclusion criteria

Inclusion Criteria:

- Females and males 18-45 years of age

- Sputum smear-positive, and confirmed by polymerase chain reaction and culture

- Obtained informed consent

Exclusion Criteria:

- Pregnancy or Lactating (assessed by pregnancy test)

- Body weight <40 kg

- Severe anaemia (Hb <70 g/L)

- HIV positive (assessed by HIV test)

- Positive rapid malaria antigen test

- Intake of mineral/vitamin supplements 2 weeks before and during the study

- Diagnosed metabolic or gastrointestinal disorders, eating disorders or food allergy

- Blood transfusion, blood donation or significant blood loss (accident, surgery) over
the past 6 months

- Subject who cannot be expected to comply with study protocol (e.g. non-residents to
the Bagamoyo Coast region, or subjects who plan to travel or move)



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Other: Stable iron isotopes, non-drug intervention

Primary Outcome(s)

Change from baseline in iron absorption of stable isotope tracers at week 24 [Time Frame: baseline, 24 weeks]

Change from baseline in iron absorption of stable isotope tracers at week 8 [Time Frame: baseline, 8 weeks]

Change from baseline in iron incorporation of stable isotope tracers at week 8 [Time Frame: baseline, 8 weeks]

Change from baseline in iron incorporation of stable isotope tracers at week 24 [Time Frame: baseline, 24 weeks]

Secondary Outcome(s)

Change from baseline in serum hepcidin at week 12 [Time Frame: baseline, 12 weeks]

Change from baseline in serum hepcidin at week 16 [Time Frame: baseline, 16 weeks]

Change from baseline in serum hepcidin at week 2 [Time Frame: baseline, 2 weeks]

Change from baseline in serum hepcidin at week 26 [Time Frame: baseline, 26 weeks]

Change from baseline in serum hepcidin at week 22 [Time Frame: baseline, 22 weeks]

Change from baseline in serum hepcidin at week 24 [Time Frame: baseline, 24 weeks]

Change from baseline in serum hepcidin at week 14 [Time Frame: baseline, 14 weeks]

Change from baseline in serum hepcidin at week 18 [Time Frame: baseline, 18 weeks]

Change from baseline in serum hepcidin at week 8 [Time Frame: baseline, 8 weeks]

Change from baseline in serum hepcidin at week 4 [Time Frame: baseline, 4 weeks]

Change from baseline in serum hepcidin at week 6 [Time Frame: baseline, 6 weeks]

Change from baseline in serum hepcidin at week 10 [Time Frame: baseline, 10 weeks]

Change from baseline in serum hepcidin at week 20 [Time Frame: baseline, 20 weeks]

Secondary ID(s)

Fe_TB_Study_TZ

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Swiss Tropical & Public Health Institute

Ifakara Health Institute