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

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.

Conditions

• Thiamin Deficiency

Interventions

OTHER

Thiamin fortified fish sauce (low concentration)

Low concentration thiamin fortified fish sauce will be consumed ad libitum for 6 months, with biweekly monitoring and evaluation to assess fish sauce usage by household and to re-stock fish sauce within the home.

OTHER

Thiamin fortified fish sauce (higher concentration)

Higher concentration thiamin fortified fish sauce will be consumed ad libitum for 6 months, with biweekly monitoring and evaluation to assess fish sauce usage by household and to re-stock fish sauce within the home.

OTHER

Placebo fish sauce

Fish sauce fortified only with iron, not thiamin, will be consumed ad libitum for 6 months, with biweekly monitoring and evaluation to assess fish sauce usage by household and to re-stock fish sauce within the home.

Sponsors & Collaborators

• Helen Keller International

  collaborator OTHER

• Grand Challenges Canada

  collaborator OTHER

• International Development Research Centre, Canada

  collaborator OTHER_GOV

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• University of British Columbia

  lead OTHER

Principal Investigators

• Tim J Green, PhD · University of British Columbia

• Kyly C Whitfield, MSc · University of British Columbia

• Judy McLean, PhD · University of British Columbia

• Zaman Talukder, MPH · Helen Keller International

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2015-04-30

Completion

2016-04-30

Countries

• Cambodia