G-PUR® for Reduced Lead Bioavailability (NCT04138693) | Clinical Trial Compass
CompletedNot Applicable
G-PUR® for Reduced Lead Bioavailability
Austria42 participantsStarted 2019-09-24
Plain-language summary
This is a prospective, randomized, placebo-controlled, double blind, parallel-arm study in a two-staged approach that will assess the effect of two different doses of G-PUR® on enteral lead absorption in healthy adults using a stable lead isotopic tracer (204Pb).
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Healthy male and female subjects
✓. Age 18-45 years
✓. BMI 19-27 for males and BMI 17-25 for female
✓. Blood lead (PbB) concentration \< 40 μg/l
✓. Serum ferritin concentration within the sex-specific normal range, i.e. ≥ 15 - 150 ng/ml for women and 30 - 400 ng/ml for men
✓. Presence of scalp hair with a minimum length of 5 mm and willingness to remove 5 single hairs with hair roots at end of study visit
✓. Subject is in good clinical and mental health as established by medical history and physical examination
✓. Stable eating habits, within one month before the start of the study
Exclusion criteria
✕. Pregnancy and breastfeeding
✕. Lack of willingness or capacity to co-operate appropriately
✕. Regular use of medications or iron supplements in the previous 2 months except intake of contraceptives
✕. Planning to shave head during study
✕. History of malignancies within the past two years or on current anticancer treatment