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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 June 2016 |
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Main ID: |
NCT02221063 |
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Date of registration:
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18/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Thiamin Fortified Fish Sauce as a Means of Combating Infantile Beriberi in Rural Cambodia
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Scientific title:
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Thiamin Fortified Fish Sauce as a Means of Combating Infantile Beriberi in Rural Cambodia |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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366 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02221063 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Phase:
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Phase 1
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Countries of recruitment
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Cambodia
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Contacts
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Name:
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Tim J Green, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Judy McLean, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Zaman Talukder, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Helen Keller International |
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Name:
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Kyly C Whitfield, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Women of Childbearing Age Cohort:
- be the female head of their household,
- have at least one child between 12 - 59 months of age at baseline,
- be living in Prey Veng province, Cambodia, and not planning to move in the next six
months,
- agree to exclusively feed her entire household the study fish sauce for six months,
and
- be willing to provide venous blood samples at baseline and endline.
Pregnant Women Cohort:
- be the female head of their household,
- be ~3-8 mo pregnant with a singleton fetus at baseline,
- have no prior history of preeclampsia, pre-term delivery, or birth defects,
- know her approximate due date,
- be living in Prey Veng province, Cambodia, and not planning to move in the next six
months,
- agree to exclusively feed her entire household the study fish sauce for six months,
and
- be willing to provide venous blood samples at baseline and endline, a breast milk
sample at endline, and to allow for a blood sample to be taken from her infant (aged
~3 months) at endline.
Exclusion Criteria:
Women of Childbearing Age Cohort:
- not be receiving any other intervention (for example, homestead food production),
- not be pregnant or hoping to become pregnant within the next 6 months, and
- not be taking any supplement that contains thiamin.
Pregnant Women Cohort:
- not be receiving any other intervention (for example, homestead food production), and
- not be taking any supplement that contains thiamin.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Thiamin Deficiency
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Intervention(s)
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Other: Placebo fish sauce
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Other: Thiamin fortified fish sauce (low concentration)
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Other: Thiamin fortified fish sauce (higher concentration)
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Primary Outcome(s)
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Erythrocyte thiamin diphosphate
[Time Frame: Baseline (t=0), Endline (t=6 months)]
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Secondary Outcome(s)
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Breast milk thiamin concentration
[Time Frame: Endline (t=6 months)]
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Secondary ID(s)
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S6 0490-01-10
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H14-00103
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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