NCT03520621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
Last Updated

May 11, 2018

Status Verified

April 1, 2018

Enrollment Period

2 months

First QC Date

April 17, 2018

Last Update Submit

April 26, 2018

Conditions

Kwashiorkor

Keywords

sulfur amino acid

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • calories and protein in diet per kg of body weight

    one measure at one time point within three weeks of registration

  • urinary sulfate

    one measure at one time point within three weeks of registration

Other Outcomes (3)

  • urinary thiocyanate

    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)

    one measure at one time point within three weeks of registration

  • physical measurements of the subject's body size

    one measure at one time point within three weeks of registration

Study Arms (2)

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

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

Interventions

No interventionOTHER

no intervention

High Prevalence PopulationLow Prevalence Population

Eligibility Criteria

Age36 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • resident of the selected population
  • in the appropriate age range

You may not qualify if:

  • caregiver reports the child has an illness that has required treatment for at least 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Restore Hope for Africa

Goma, North Kivu, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Kwashiorkor

Condition Hierarchy (Ancestors)

Severe Acute MalnutritionMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Daniel Maxwell, PhD

    Tufts University, Friedman School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2018

First Posted

May 11, 2018

Study Start

June 1, 2016

Primary Completion

August 14, 2016

Study Completion

August 2, 2017

Last Updated

May 11, 2018

Record last verified: 2018-04

Locations

DE(1)