The Role of Sulfur Amino Acids in Risk of Kwashiorkor

Kwashiorkor Clinical Trial

Official title:

The Role of Sulfur Amino Acids in Risk of Kwashiorkor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03520621
• Other study ID #: 1605004
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: August 2, 2017

Study information

• Verified date: April 2018
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: August 2, 2017
• Est. primary completion date: August 14, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 36 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Kwashiorkor

Intervention

Other:
• No intervention
no intervention

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Restore Hope for Africa	Goma	North Kivu

Sponsors (5)

Lead Sponsor	Collaborator
Tufts University	Action Contre la Faim, Dignitas International, Rebuild Hope for Africa, World Concern

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	urinary thiocyanate	thiocyanate excreted in the urine (ppm)	one measure at one time point within three weeks of registration
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	urinary sulfate	sulfate excreted in the urine, normalized to creatinine	one measure at one time point within three weeks of registration