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High-selenium Lentils Versus Arsenic Toxicity

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ClinicalTrials.gov Identifier: NCT02429921
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
Judit E.G. Smits, University of Calgary

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.


Condition or disease Intervention/treatment Phase
Arsenic Poisoning Dietary Supplement: high-selenium lentils Dietary Supplement: Low-Se lentils Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Mitigating Arsenic Toxicity in Bangladeshi People by Supplementing Their Diets With High Selenium Lentils
Study Start Date : October 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arsenic Poisoning
Drug Information available for: Arsenic

Arm Intervention/treatment
Experimental: low-Se lentils
50 mg of low-selenium lentils per person consumed as soups
Dietary Supplement: Low-Se lentils
lentils grown on selenium-deficient soils in Idaho, USA.
Other Name: low-selenium lentils

Experimental: high-Se lentils
50 mg of high-selenium lentils per person consumed as soup
Dietary Supplement: high-selenium lentils
lentils grown on naturally selenium-rich soils in the Canadian Prairies




Primary Outcome Measures :
  1. arsenic body burden [ Time Frame: week 12 ]
    Urine, feces, and hair samples of participants will be tested for arsenic content.


Secondary Outcome Measures :
  1. Antioxidant status [ Time Frame: week 24 ]
    Blood specimen will be tested for glutathione (ox/red) levels.

  2. oxidative damage [ Time Frame: week 24 ]
    Blood specimen will be tested for 8-OHdG, a marker for oxidative DNA damage.

  3. serum lipid levels [ Time Frame: week 24 ]
    Serum will be analyzed for triglyceride, total cholesterol, HDL- and LDL-cholesterol.

  4. Lung inflammation test [ Time Frame: week 12 ]
    Participants will exhale into a NIOX Mino device, which measures the nitric oxide level as marker of lung inflammation

  5. Health and compliance questionnaires [ Time Frame: biweekly (health) for 6 months ]
    Health questionnaire (and initial sociodemographic questionnaire) will be filled in by participant every two weeks to assess overall health, and lentil consumption will be assessed weekly.

  6. Body mass index [ Time Frame: week 24 ]
    Examination by health professionals: Body mass index

  7. Blood pressure [ Time Frame: week 24 ]
    Examination by health professionals: blood pressure



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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429921


Locations
Bangladesh
Field Office, International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
University of Calgary
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Principal Investigator: Judit EG Smits, DVM, PhD University of Calgary, Calgary, Alberta, Canada
Study Director: Albert Vandenberg, PhD University of Saskatchewan

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Judit E.G. Smits, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02429921     History of Changes
Other Study ID Numbers: REB13-1211_MOD1
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017

Keywords provided by Judit E.G. Smits, University of Calgary:
dietary intervention
arsenic poisoning
high-Se lentils

Additional relevant MeSH terms:
Poisoning
Arsenic Poisoning
Chemically-Induced Disorders
Heavy Metal Poisoning, Nervous System
Neurotoxicity Syndromes
Nervous System Diseases
Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances