The Role of Sulfur Amino Acids in Risk of Kwashiorkor

NCT ID: NCT03520621

Last Updated: 2018-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-08-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Kwashiorkor

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

No intervention

Intervention Type OTHER

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

No intervention

Intervention Type OTHER

no intervention

Interventions

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No intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

36 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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World Concern

UNKNOWN

Sponsor Role collaborator

Action Contre la Faim

OTHER

Sponsor Role collaborator

Rebuild Hope for Africa

UNKNOWN

Sponsor Role collaborator

Dignitas International

OTHER

Sponsor Role collaborator

Tufts University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Maxwell, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts University, Friedman School

Locations

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Restore Hope for Africa

Goma, North Kivu, Democratic Republic of the Congo

Site Status

Countries

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Democratic Republic of the Congo

Other Identifiers

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1605004

Identifier Type: -

Identifier Source: org_study_id

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