Status:
COMPLETED
Thiamin Fortified Fish Sauce as a Means of Combating Infantile Beriberi in Rural Cambodia
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Helen Keller International
Grand Challenges Canada
Conditions:
Thiamin Deficiency
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether consumption of thiamin fortified fish sauce over 6 months increases the thiamin status of women to a level consistent with a low risk of infantile ber...
Detailed Description
Purpose The purpose of this three-armed, double blind randomized control trial is to determine whether thiamin-fortified fish sauce is an efficacious means of increasing dietary thiamin intake in Camb...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT02221063
Start Date
October 1 2014
End Date
April 1 2016
Last Update
May 25 2016
Active Locations (1)
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1
(Various Villages), Prey Veng, Cambodia