High-selenium Lentils Versus Arsenic Toxicity

NCT02429921 | Completed DMC

• 1 other identifier: REB13-1211_MOD1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

About 45 million people in Bangladesh are chronically exposed to unacceptable levels of arsenic in their drinking water. Chronic arsenic poisoning leads to cancers, and vascular diseases. This dietary trial intends to test the potential of high-selenium lentils, consumed as lentil soup, in reducing the arsenic body burden in an exposed Bangladeshi population, and in improving the overall health status. Arsenic-exposed families will be assigned to one of two groups. One group will eat lentils (50g/person/day) that are naturally high in selenium, the other group will receive lentils with low selenium content. This 6 months trial is randomized and double-blinded.

Conditions

Arsenic Poisoning

Keywords

dietary intervention; arsenic poisoning; high-Se lentils

Outcome Measures

Primary Outcomes (1)

• arsenic body burden

  Urine, feces, and hair samples of participants will be tested for arsenic content.

  week 12

Secondary Outcomes (7)

• Antioxidant status

  week 24

• oxidative damage

  week 24

• serum lipid levels

  week 24

• Lung inflammation test

  week 12

• Health and compliance questionnaires

  biweekly (health) for 6 months

Study Arms (2)

low-Se lentils

EXPERIMENTAL

50 mg of low-selenium lentils per person consumed as soups

Dietary Supplement: Low-Se lentils

high-Se lentils

EXPERIMENTAL

50 mg of high-selenium lentils per person consumed as soup

Dietary Supplement: high-selenium lentils

Interventions

high-selenium lentils DIETARY_SUPPLEMENT

lentils grown on naturally selenium-rich soils in the Canadian Prairies

high-Se lentils

Low-Se lentils DIETARY_SUPPLEMENT

lentils grown on selenium-deficient soils in Idaho, USA.

Also known as: low-selenium lentils

low-Se lentils

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• low, moderate and high arsenic levels in tube well water, that the household uses. If tube well water exceeds the national standard of 50 ppb, families will be advised to switch to another well in their proximity with lower Arsenic levels, if available.

You may not qualify if:

• Families that have very low arsenic levels (below US standard of 10 ppb) in their well water will not be enrolled.

Sponsors & Collaborators

• University of Calgary: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator

Study Sites (1)

Field Office, International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Dhaka Division, 1212, Bangladesh

Location

Related Publications (6)

• Zeng H, Uthus EO, Combs GF Jr. Mechanistic aspects of the interaction between selenium and arsenic. J Inorg Biochem. 2005 Jun;99(6):1269-74. doi: 10.1016/j.jinorgbio.2005.03.006.

  PMID: 15917080 BACKGROUND

• Gailer J, George GN, Pickering IJ, Prince RC, Younis HS, Winzerling JJ. Biliary excretion of [(GS)(2)AsSe](-) after intravenous injection of rabbits with arsenite and selenate. Chem Res Toxicol. 2002 Nov;15(11):1466-71. doi: 10.1021/tx025538s.

  PMID: 12437338 BACKGROUND

• Thavarajah D, Vandenberg A, George GN, Pickering IJ. Chemical form of selenium in naturally selenium-rich lentils (Lens culinaris L.) from Saskatchewan. J Agric Food Chem. 2007 Sep 5;55(18):7337-41. doi: 10.1021/jf070681i. Epub 2007 Aug 9.

  PMID: 17685630 BACKGROUND

• Thavarajah D, Ruszkowski J, Vandenberg A. High potential for selenium biofortification of lentils ( Lens culinaris L.). J Agric Food Chem. 2008 Nov 26;56(22):10747-53. doi: 10.1021/jf802307h.

  PMID: 18954072 BACKGROUND

• Thavarajah, D., et al. (2011), 'A global survey of effects of genotype and environment on selenium concentration in lentils (Lens culinaris L.): Implications for nutritional fortification strategies', Food Chemistry, 125 (1), 72-76.

  BACKGROUND

• Krohn RM, Raqib R, Akhtar E, Vandenberg A, Smits JE. A high-selenium lentil dietary intervention in Bangladesh to counteract arsenic toxicity: study protocol for a randomized controlled trial. Trials. 2016 Apr 27;17(1):218. doi: 10.1186/s13063-016-1344-y.

  PMID: 27121115 DERIVED

Related Links

• WHO: Arsenic: Fact Sheet No. 372, December 2012. 2012.

MeSH Terms

Conditions

Arsenic Poisoning

Condition Hierarchy (Ancestors)

Heavy Metal Poisoning, Nervous System; Neurotoxicity Syndromes; Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Judit EG Smits, DVM, PhD

  University of Calgary, Calgary, Alberta, Canada

  PRINCIPAL INVESTIGATOR

• Albert Vandenberg, PhD

  University of Saskatchewan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 29, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 31, 2017

Record last verified: 2017-03

Locations

BA (1)