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Table 1 WHO Trial Registration Minimal Data Set according to Moja et al. [22]

From: A high-selenium lentil dietary intervention in Bangladesh to counteract arsenic toxicity: study protocol for a randomized controlled trial

Data Information
Trial identification number ClinicalTrials.gov NCT02429921
Trial registration date April 21, 2015
Secondary IDs REB13-1211 (CHREB, University of Calgary), PR-14013 (ERC, icddr,b)
Funding sources Global Institute for Food Security (GIFS); Grand Challenges Canada - Stars in Global Health Round 5
Primary sponsor JEGS, Faculty of Vet. Med, University of Calgary, Canada
Secondary sponsor RR, icddr,b, Dhaka, Bangladesh
Responsible contact person RR, icddr,b; rubhana@icddrb.org
Research contact person JEGS, Faculty of Vet. Med., University of Calgary; jegsmits@ucalgary.ca
Brief title of the study High-selenium Lentils Versus Arsenic Toxicity
Official title of the study Mitigating arsenic toxicity in Bangladeshi people by supplementing their diets with high selenium lentils
Country of recruitment Bangladesh
Health problem studied Chronic arsenic poisoning
Intervention High-selenium lentils, control: low-selenium lentils
Key inclusion and exclusion criteria Inclusion criteria: families with >100 ppb As in their well water; ages eligible for study: 14–75
Exclusion criteria: As content of well water ≤100 ppb; ill health detected during initial recruitment health check
Study type Double blind, parallel, block-randomized, controlled intervention trial
Trial start date September 28, 2015
Target sample size 200 per treatment group (400 in total)
Recruitment status Active
Primary outcome Arsenic body burden: We will determine if high-Se lentil consumption will decrease the body burden of As by measurement of As excretion in urine and feces and deposition in hair
Key secondary outcomes We will determine if high-Se lentils:
1. Increase concentrations of protective antioxidants and reduce oxidative stress and acute phase response in blood
2. Modulate serum lipid profile and blood pressure
3. Reduce As-related lung inflammation