KwashiorkorNCT03520621
The Role of Sulfur Amino Acids in Risk of Kwashiorkor
An observational study of Kwashiorkor, run by Tufts University at 1 site in Democratic Republic of the Congo.
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. Read more about this study
- Who is it for?
- Ages 36 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Kwashiorkor
- How many people
- 360 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 1 Jun 2016to 2 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population, both groups, live within a 3 mile by 3 mile square in rural eastern Democratic Republic of the Congo.
Who may be able to join
- resident of the selected population
- in the appropriate age range
Who cannot join
- caregiver reports the child has an illness that has required treatment for at least 6 months
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Restore Hope for Africa
Goma, North Kivu
About this study
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.
Read the 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.
- Conditions
- Kwashiorkor
- Being tested
- No intervention
- Keywords
- sulfur amino acid
- Medical subject headings
- Kwashiorkor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary sulfur amino acid
mg of sulfur amino acid in the diet per kg of body weight
Measured: 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
Measured: one measure at one time point within three weeks of registration
Secondary outcomes (2)
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
Measured: one measure at one time point within three weeks of registration
urinary sulfate
sulfate excreted in the urine, normalized to creatinine
Measured: one measure at one time point within three weeks of registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Jun 2016
- Primary completion14 Aug 2016
- Study completion2 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KwashiorkorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- World Concern, Action Contre la Faim, Rebuild Hope for Africa, Dignitas International
- Responsible party
- Sponsor
- Investigators
- Daniel Maxwell, PhD, Principal investigator, Tufts University, Friedman School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520621
- Sponsor's protocol ID
- 1605004
- Status last verified
- Apr 2018
- First submitted
- 17 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sulfur Amino Acids in Risk of Kwashiorkor
- ClinicalTrials.gov ID
- NCT03520621
- Acronym / sponsor ID
- 1605004
- Conditions
- Kwashiorkor
- Keywords
- sulfur amino acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- World Concern, Action Contre la Faim, Rebuild Hope for Africa, Dignitas International
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 14 Aug 2016 (actual)
- Study completion
- 2 Aug 2017 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Prevalence Population | – | Other: No interventionPrevalence 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 |
| Low Prevalence Population | – | Other: No interventionPrevalence 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 |
Who may qualify
- Ages
- 36 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population, both groups, live within a 3 mile by 3 mile square in rural eastern Democratic Republic of the Congo.
Key inclusion criteria (2 listed)
- resident of the selected population
- in the appropriate age range
Key exclusion criteria (1 listed)
- caregiver reports the child has an illness that has required treatment for at least 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionno intervention | Other | High Prevalence Population, Low Prevalence Population |
Primary outcome
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
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
2 secondary outcomes
calories and protein in diet per kg of body weight
Time frame: one measure at one time point within three weeks of registration
urinary sulfate
Time frame: one measure at one time point within three weeks of registration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Maxwell, PhD principal investigator
Tufts University, Friedman School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kwashiorkor, run by Tufts University at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary sulfur amino acid (time frame: one measure at one time point within three weeks of registration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.