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.

Study Overview

• Status: Completed
• Conditions: Kwashiorkor
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 360

Contacts and Locations

Study Locations

• Congo, The Democratic Republic of the
  • North Kivu
    • Goma, North Kivu, Congo, The Democratic Republic of the
      • Restore Hope for Africa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary sulfur amino acid	mg of sulfur amino acid in the diet per kg of body weight	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	one measure at one time point within three weeks of registration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one measure at one time point within three weeks of registration
urinary sulfate	sulfate excreted in the urine, normalized to creatinine	one measure at one time point within three weeks of registration

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
urinary thiocyanate	thiocyanate excreted in the urine (ppm)	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	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)	one measure at one time point within three weeks of registration

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: Action Contre la Faim; World Concern; Rebuild Hope for Africa; Dignitas International
• Investigators: Principal Investigator: Daniel Maxwell, PhD, Tufts University, Friedman School

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): August 14, 2016
• Study Completion (Actual): August 2, 2017

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 26, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: sulfur amino acid
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Severe Acute Malnutrition; Kwashiorkor
• Other Study ID Numbers: 1605004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No