Clinical trial NCT03520621: The Role of Sulfur Amino Acids in Risk of Kwashiorkor
Official title: The Role of Sulfur Amino Acids in Risk of Kwashiorkor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kwashiorkor
Keywords: sulfur amino acid
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: World Concern
name: Action Contre la Faim
name: Rebuild Hope for Africa
name: Dignitas International
First posted: 2018-05-11
Enrollment: 360
Sex: ALL
Minimum age (years): 36
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Dietary sulfur amino acid
timeFrame: one measure at one time point within three weeks of registration
measure: dietary sulfur amino acid above or below WHO estimated average requirement (EAR)
timeFrame: one measure at one time point within three weeks of registration
Secondary outcomes:
measure: calories and protein in diet per kg of body weight
timeFrame: one measure at one time point within three weeks of registration
measure: urinary sulfate
timeFrame: one measure at one time point within three weeks of registration
Other outcomes:
measure: urinary thiocyanate
timeFrame: one measure at one time point within three weeks of registration
measure: socio-environmental factors (use of a latrine, shelter description, feeding habits, household demographics, health history)
timeFrame: one measure at one time point within three weeks of registration
measure: physical measurements of the subject's body size
timeFrame: one measure at one time point within three weeks of registration
Locations:
city: Goma
country: Congo, The Democratic Republic of the
facility: Restore Hope for Africa
state: North Kivu
Study officials:
affiliation: Tufts University, Friedman School
name: Daniel Maxwell, PhD
role: PRINCIPAL_INVESTIGATOR
References: