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The Role of Sulfur Amino Acids in Risk of Kwashiorkor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03520621
Recruitment Status : Completed
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Collaborators:
World Concern
Action Contre la Faim
Rebuild Hope for Africa
Dignitas International
Information provided by (Responsible Party):
Tufts University

Brief Summary:
This observational cross-sectional study is investigating if young children in populations with higher prevalence of kwashiorkor malnutrition have lower dietary sulfur amino acid intake than populations with lower prevalence of kwashiorkor, controlling for multiple potential confounding factors. Intake is estimated through diet recalls during interviews with a child's caregiver, analysis of urine samples and analysis of food samples for their amino acid profiles.

Condition or disease Intervention/treatment
Kwashiorkor Other: No intervention

Detailed Description:

Kwashiorkor is one of two categorizations of severe acute malnutrition, but its etiology remains unclear. Although kwashiorkor is found only where diets are low in quality protein, comparisons of total dietary protein of individual children with and without kwashiorkor has been inconclusive. This study aims to compare amino acid profiles of the diets, not just total protein.

Evidence has shown that children with kwashiorkor consistently have very low circulating levels of sulfur amino acids (cysteine and methionine). Typical staple foods in regions with endemic kwashiorkor are generally poor in sulfur amino acids and the signs characterizing kwashiorkor can plausibly be explained by a shortage of sulfur amino acids.

In eastern Democratic Republic of the Congo, certain populations have chronically higher prevalence of kwashiorkor than neighboring populations with similar livelihoods, religion, environment, language and ethnicity. This study will compare these two populations to understand what differences between them may explain the difference in prevalence.

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Study Type : Observational
Actual Enrollment : 360 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Role of Sulfur Amino Acids in Risk of Kwashiorkor
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : August 14, 2016
Actual Study Completion Date : August 2, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
High Prevalence Population
Prevalence of kwashiorkor (as diagnosed by bipedal pitting edema) is >2% among children 36 to 59 months old in the population, in Murambi/Malehe Health Area of eastern Democratic Republic of the Congo
Other: No intervention
no intervention

Low Prevalence Population
Prevalence of kwashiorkor (as diagnosed by bipedal pitting edema) is <2% among children 36 to 59 months old in the population, in Murambi/Malehe Health Area of eastern Democratic Republic of the Congo
Other: No intervention
no intervention




Primary Outcome Measures :
  1. Dietary sulfur amino acid [ Time Frame: one measure at one time point within three weeks of registration ]
    mg of sulfur amino acid in the diet per kg of body weight

  2. dietary sulfur amino acid above or below WHO estimated average requirement (EAR) [ Time Frame: one measure at one time point within three weeks of registration ]

    the total sulfur amino acid in the diet will be calculated from a diet recall

    this will be a bivariate measure, "1" if the SAA in the diet is above or "0" if below the WHO/FAO requirement for sulfur amino acid intake of 17mg of sulfur amino acids per kg of body weight per day



Secondary Outcome Measures :
  1. calories and protein in diet per kg of body weight [ Time Frame: one measure at one time point within three weeks of registration ]

    intake of calories (kcal/kg body weight),

    digestibility adjusted protein - sum of (grams of protein per food item x digestibility of food item) per kg of body weight

    quality adjusted protein = digestibility adjusted protein in the diet x proportion of requirement of the limiting amino acid


  2. urinary sulfate [ Time Frame: one measure at one time point within three weeks of registration ]
    sulfate excreted in the urine, normalized to creatinine


Other Outcome Measures:
  1. urinary thiocyanate [ Time Frame: one measure at one time point within three weeks of registration ]
    thiocyanate excreted in the urine (ppm)

  2. socio-environmental factors (use of a latrine, shelter description, feeding habits, household demographics, health history) [ Time Frame: one measure at one time point within three weeks of registration ]
    sanitation - does the child use a latrine, defecate in the woods/fields, defecate around the home shelter - materials used for the roof and walls, size of the home in square meters feeding habits - number of hot meals per day, number of feeding episodes per day household demographics - age and sex of all people who eat and sleep regularly at that homestead health history - illnesses in the past 30 days, previous diagnoses of malnutrition and type of malnutrition

  3. physical measurements of the subject's body size [ Time Frame: one measure at one time point within three weeks of registration ]
    height to the nearest mm, weight to the nearest 100g, middle-upper arm circumference to the nearest mm, visual signs of kwashiorkor (edema, rough or darkened skin, friable lightened hair, distended abdomen, lethargy or irritability)



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Ages Eligible for Study:   36 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population, both groups, live within a 3 mile by 3 mile square in rural eastern Democratic Republic of the Congo.
Criteria

Inclusion Criteria:

  • resident of the selected population
  • in the appropriate age range

Exclusion Criteria:

  • caregiver reports the child has an illness that has required treatment for at least 6 months

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): NCT03520621


Locations
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Congo, The Democratic Republic of the
Restore Hope for Africa
Goma, North Kivu, Congo, The Democratic Republic of the
Sponsors and Collaborators
Tufts University
World Concern
Action Contre la Faim
Rebuild Hope for Africa
Dignitas International
Investigators
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Principal Investigator: Daniel Maxwell, PhD Tufts University, Friedman School

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Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT03520621    
Other Study ID Numbers: 1605004
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tufts University:
sulfur amino acid
Additional relevant MeSH terms:
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Kwashiorkor
Severe Acute Malnutrition
Malnutrition
Nutrition Disorders