An observational study in Kwashiorkor, sponsored by Tufts University. Completed at 1 site in Congo, The Democratic Republic of the. Open to participants aged 36 Months to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-11.
Sponsored by Tufts University · Observational
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.
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.
44 studies on the registry are indexed under Kwashiorkor; 6 are open to participants now.
This study's enrollment of 360 is above the median of 82 across 11 observational studies indexed under Kwashiorkor.
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The study population, both groups, live within a 3 mile by 3 mile square in rural eastern Democratic Republic of the Congo.
Exclusion Criteria:
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
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
Dietary sulfur amino acid
mg of sulfur amino acid in the diet per kg of body weight
Time frame: one measure at one time point within three weeks of registration
dietary sulfur amino acid above or below WHO estimated average requirement (EAR)
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
Time frame: one measure at one time point within three weeks of registration
calories and protein in diet per kg of body weight
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
Time frame: one measure at one time point within three weeks of registration
urinary sulfate
sulfate excreted in the urine, normalized to creatinine
Time frame: one measure at one time point within three weeks of registration
urinary thiocyanate
thiocyanate excreted in the urine (ppm)
Time frame: one measure at one time point within three weeks of registration
socio-environmental factors (use of a latrine, shelter description, feeding habits, household demographics, health history)
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
Time frame: one measure at one time point within three weeks of registration
physical measurements of the subject's body size
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)
Time frame: one measure at one time point within three weeks of registration
Plan to share: Undecided
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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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