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NCT Number: NCT03520621

The Role of Sulfur Amino Acids in Risk of Kwashiorkor

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.

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Key information

Conditions

Kwashiorkor Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Severe Acute Malnutrition

Age range

36 month–59 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Restore Hope for Africa

Goma, North Kivu, Democratic Republic of the Congo

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • Action Contre la Faim
  • Dignitas International
  • Rebuild Hope for Africa
  • World Concern

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 11, 2018
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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