NCT04138693

G-PUR® for Reduced Lead Bioavailability

A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effect of G-PUR® on Enteral Lead Isotope 204Pb-absorption

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Glock Health, Science and Research GmbH · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Conditions

• Lead Exposure

Interventions

Type	Name	Description
DEVICE	G-PUR® 2x 2.0 g oral suspension	Cohort 1: 2 g G-PUR® powder mixed with 100 ml water in an opaque drinking bottle will be orally administered before and immediately after 204Pb intake
DEVICE	G-PUR® 1x 2.0 g oral suspension	Cohort 2: 2 g G-PUR® powder mixed with 100 ml water in an opaque drinking bottle will be orally administered before 204Pb intake and 100 ml water (placebo) in an opaque drinking bottle immediately after 204Pb intake
DEVICE	Placebo oral suspension	Cohort 3: 100 ml of water in an opaque drinking bottle will be orally administered immediately before and after 204Pb intake

Timeline

• Start date: 2019-09-24
• Primary completion: 2020-02-12
• Completion: 2020-02-12
• First posted: 2019-10-24
• Last updated: 2020-06-04

Locations

1 site across 1 country: Austria