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Trial record 2 of 22 for:    "Beriberi"

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

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ClinicalTrials.gov Identifier: NCT02221063
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : May 25, 2016
Sponsor:
Collaborators:
Helen Keller International
Grand Challenges Canada
International Development Research Centre, Canada
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Thiamin Deficiency Other: Thiamin fortified fish sauce (low concentration) Other: Thiamin fortified fish sauce (higher concentration) Other: Placebo fish sauce Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Thiamin Fortified Fish Sauce as a Means of Combating Infantile Beriberi in Rural Cambodia
Study Start Date : October 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: low [thiamin] fortified fish sauce
Fish sauce will contain 2 mg thiamin hydrochloride / mL fish sauce + iron (as NaFeEDTA)
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.

Active Comparator: higher [thiamin] fortified fish sauce
Fish sauce will contain 8 mg thiamin hydrochloride / mL fish sauce + iron (as NaFeEDTA)
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.

Placebo Comparator: Placebo fish sauce
Fish sauce will contain only iron (as NaFeEDTA), no thiamin
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221063


Locations
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Cambodia
(Various Villages), Prey Veng, Cambodia
Sponsors and Collaborators
University of British Columbia
Helen Keller International
Grand Challenges Canada
International Development Research Centre, Canada
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Tim J Green, PhD University of British Columbia
Study Director: Kyly C Whitfield, MSc University of British Columbia
Study Chair: Judy McLean, PhD University of British Columbia
Study Chair: Zaman Talukder, MPH Helen Keller International

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02221063     History of Changes
Other Study ID Numbers: H14-00103
S6 0490-01-10 ( Other Identifier: Grand Challenges Canada )
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016

Keywords provided by University of British Columbia:
thiamin
thiamin diphosphate
beriberi
Cambodia
fish sauce
fortification
pregnancy
breastfeeding
childbearing age

Additional relevant MeSH terms:
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Thiamine Deficiency
Beriberi
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Thiamine
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs