NCT02221063

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 25, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

August 18, 2014

Last Update Submit

May 24, 2016

Conditions

Thiamin Deficiency

Keywords

thiaminthiamin diphosphateberiberiCambodiafish saucefortificationpregnancybreastfeedingchildbearing age

Outcome Measures

Primary Outcomes (1)

  • Erythrocyte thiamin diphosphate

    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.

    Baseline (t=0), Endline (t=6 months)

Secondary Outcomes (1)

  • Breast milk thiamin concentration

    Endline (t=6 months)

Study Arms (3)

low [thiamin] fortified fish sauce

ACTIVE COMPARATOR

Fish sauce will contain 2 mg thiamin hydrochloride / mL fish sauce + iron (as NaFeEDTA)

Other: Thiamin fortified fish sauce (low concentration)

higher [thiamin] fortified fish sauce

ACTIVE COMPARATOR

Fish sauce will contain 8 mg thiamin hydrochloride / mL fish sauce + iron (as NaFeEDTA)

Other: Thiamin fortified fish sauce (higher concentration)

Placebo fish sauce

PLACEBO COMPARATOR

Fish sauce will contain only iron (as NaFeEDTA), no thiamin

Other: Placebo fish sauce

Interventions

Thiamin fortified fish sauce (low concentration)OTHER

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.

low [thiamin] fortified fish sauce
Thiamin fortified fish sauce (higher concentration)OTHER

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.

higher [thiamin] fortified fish sauce
Placebo fish sauceOTHER

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.

Placebo fish sauce

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

(Various Villages), Prey Veng, Cambodia

Location

Related Publications (2)

  • Whitfield KC, Karakochuk CD, Kroeun H, Sokhoing L, Chan BB, Borath M, Sophonneary P, Moore K, Tong JKT, McLean J, Talukder A, Lynd LD, Li-Chan ECY, Kitts DD, Green TJ. Household Consumption of Thiamin-Fortified Fish Sauce Increases Erythrocyte Thiamin Concentrations among Rural Cambodian Women and Their Children Younger Than 5 Years of Age: A Randomized Controlled Efficacy Trial. J Pediatr. 2017 Feb;181:242-247.e2. doi: 10.1016/j.jpeds.2016.10.066. Epub 2016 Dec 7.

    PMID: 27939124DERIVED

  • Whitfield KC, Karakochuk CD, Kroeun H, Hampel D, Sokhoing L, Chan BB, Borath M, Sophonneary P, McLean J, Talukder A, Lynd LD, Li-Chan EC, Kitts DD, Allen LH, Green TJ. Perinatal Consumption of Thiamine-Fortified Fish Sauce in Rural Cambodia: A Randomized Clinical Trial. JAMA Pediatr. 2016 Oct 3;170(10):e162065. doi: 10.1001/jamapediatrics.2016.2065. Epub 2016 Oct 3.

    PMID: 27532780DERIVED

MeSH Terms

Conditions

BeriberiBreast Feeding

Condition Hierarchy (Ancestors)

Thiamine DeficiencyVitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesFeeding BehaviorBehavior

Study Officials

  • Tim J Green, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Kyly C Whitfield, MSc

    University of British Columbia

    STUDY DIRECTOR

  • Judy McLean, PhD

    University of British Columbia

    STUDY CHAIR

  • Zaman Talukder, MPH

    Helen Keller International

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2014

First Posted

August 20, 2014

Study Start

October 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2016

Last Updated

May 25, 2016

Record last verified: 2016-05

Locations

CA(1)