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