Clinical Trial: Thiamin Fortified Fish Sauce as a Means of Combating Infantile Beriberi in Rural Cambodia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Thiamin Fortified Fish Sauce as a Means of Combating Infantile Beriberi in Rural Cambodia

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 beriberi. The investigators hypothesize that consumption of thiamin-fortified fish sauce will increase red blood cell thiamin concentrations, an indicator of thiamin status, in women consuming thiamin-fortified fish sauce, while concentrations will not change in women consuming a placebo fish sauce that does not contain thiamin.

Detailed Summary:

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 Cambodian women to a level that increases erythrocyte thiamin diphosphate (TDP) concentrations to a level consistent with a low risk of infantile beriberi. Two groups of women will participate in this study: women of childbearing age (18-45y; n=270), and pregnant women (18-45y; ~26 weeks pregnant at baseline; n=90).

Hypothesis Intervention with thiamin-fortified fish sauce will increase women's TDP concentrations to levels consistent with a low risk of infantile beriberi compared to those receiving the control fish sauce.

Study Justification Beriberi is a micronutrient deficiency disease caused by a lack of thiamin (vitamin B1) in the diet. Infantile beriberi is common in Southeast Asia.

Beriberi, a disease caused by severe thiamin deficiency, is rare in the west but is thought to be more common in developing countries, particularly those in Southeast Asia. In infants, beriberi presents with symptoms of heart failure and is fatal unless thiamin treatment is initiated immediately. Beriberi typically presents in exclusively breastfed infants whose mothers have suboptimal thiamin status and consequently have low breast milk thiamin concentrations. Maternal thiamin deficiency in Cambodia is likely a result of multiple factors: the high consumption of white, polished rice, which has been removed from its B-vitamin-containing husk, a lack of parboiling rice, and low dietary diversity. Improving the thiamin status of pregnant and lactating women is essential for combating infantile beriberi. Fortification of a food staple has proven to be a successful strategy in increasing population lev
Sponsor: University of British Columbia

Current Primary Outcome: Erythrocyte thiamin diphosphate [ Time Frame: Baseline (t=0), Endline (t=6 months) ]

Measurement at baseline and endline for all women. Blood samples from infants of women recruited in the pregnancy cohort will be collected at endline only.


Original Primary Outcome: Erythrocyte thiamin diphosphate [ Time Frame: Baseline (t=0), Endline (t=6 months) ]

Measurement at baseline and endline for all women. Heel prick blood samples from infants of women recruited in the pregnancy cohort will be collected at endline only.


Current Secondary Outcome: Breast milk thiamin concentration [ Time Frame: Endline (t=6 months) ]

Breast milk will collected only from those women recruited in the pregnancy cohort (n=90)


Original Secondary Outcome: Same as current

Information By: University of British Columbia

Dates:
Date Received: August 18, 2014
Date Started: October 2014
Date Completion:
Last Updated: May 24, 2016
Last Verified: May 2016