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

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 levels of thiamin because as a 'passive' intervention, it requires little to no behavior change. Fish sauce is an ideal vehicle for thiamin fortification: it is consumed daily in consistently high quantities, and is produced in centralized plants, and has been successfully used in Cambodia and Vietnam as a vehicle for iron fortification.

Research Method All villages in Prey Veng province that are not already involved in an active intervention (for example, homestead food production, micronutrient powder intervention etc) will be randomized. A Khmer-speaking research assistant will contact the Village Chief and/or Village Health Volunteer in the first village on the randomized list and determine the number of eligible women of childbearing age and pregnant women (~26 weeks) in that village. The research assistant will move down the randomized list of villages until 360 participants have been enrolled. The investigators expect enrolment from approximately 10 villages.