Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02221063 |
| Other study ID # |
H14-00103 |
| Secondary ID |
S6 0490-01-10 |
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
August 18, 2014 |
| Last updated |
May 24, 2016 |
| Start date |
October 2014 |
| Est. completion date |
April 2016 |
Study information
| Verified date |
May 2016 |
| Source |
University of British Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Canada: Health CanadaCambodia: Ministry of HealthCambodia: National Sub-Committee for Food Fortification, Ministry of Planning |
| Study type |
Interventional
|
Clinical Trial 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.
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 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.
A trained, Khmer-speaking enumerator will conduct an interview in the participants home. The
questionnaire will collect demographic data, as well as information on dietary intake
(including fish sauce), thoughts and perceptions of fortified products, and knowledge of
thiamin deficiency and beriberi. Once the questionnaire is complete the participant will
walk with the interviewer to a central meeting spot within the village (typically the
Village Chief's home) to complete anthropometric measurements (height and weight). The next
morning the participant will travel to the local health centre for a non-fasted blood draw.
Once the participant completes the baseline questionnaire, anthropometrics, and blood
collection she will be randomly assigned to one of the three treatment groups: low
concentration thiamin-iron-fortified fish sauce (2mg thiamin/mL fish sauce + iron), higher
concentration thiamin-fortified fish sauce (8mg thiamin/mL fish sauce + iron), or placebo:
iron-fortified fish sauce. The bottles and labels of the three fish sauces will be identical
in appearance, except for a code that differentiates the sauces.
All participants will be visited biweekly for monitoring and evaluation of fish sauce
consumption. Fish sauce will be distributed during these visits to ensure that there are no
'stock outs' of fish sauce during the study.
Within the first month of the study all participants will attend an educational workshop
with training regarding dietary thiamin intake, thiamin deficiency and beriberi, and infant
and young child feeding (IYCF) practices.
Anthropometric measurements (weight and length) will be taken within 72 hours of the birth
of the participant's infant (t~3 months).
At t~4 months, a subset of households (n=28) will participate in an Observed Weighed Fish
Sauce Record wherein a trained enumerator measure all fish sauce consumed by the participant
throughout one day. Two repeat observed weighed fish sauce records will be completed within
a 2 week period.
At endline (t=6 months), the questionnaire, anthropometrics, and blood draw will be repeated
with all women. The investigators will also collect a venous blood sample (4mL) from the
infant, and a breast milk sample from mothers from the pregnant cohort. Investigators plan
to analyze all samples within two months of the endline sample collection, and will return
to the villages to share study findings with all participants at a community meeting
(general results shared), and then separately to share individual thiamin results
one-on-one. All participants will have already participated in an educational workshop
highlighting the importance of dietary thiamin intake, and the signs of thiamin deficiency
and beriberi. Individuals with suboptimal thiamin status will be encouraged to speak with
their healthcare provider, and will also be counselled using the materials that were
previously used in the educational workshop.
