An interventional study of Whole egg powder and Corn powder in Moderate Acute Malnutrition, Stunting and Environmental Enteric Dysfunction, sponsored by Washington University School of Medicine. Completed at 10 sites in Sierra Leone. Open to participants aged 6 Months to 30 Months. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to test egg powder supplementation in children with moderate acute malnutrition in Sierra Leone. The main question it aims to answer is:
Undernutrition in children manifests as wasting, stunting, or both. While wasting is generally responsive to high-quality nutritional interventions, stunting is less so. Affected children are at increased risk of acute and chronic illnesses, have reduced neurocognitive development, lower academic achievement, reduced adult earning potential, and shortened lifespans. Given that stunting affects over 140 million children at any one time, the costs incurred are deep and broad, particularly among children in sub-Saharan Africa, where nearly half of the world's population growth is expected to occur over the next 30 years. Part of the challenge of treating stunting has been attributed to environmental enteric dysfunction (EED), an acquired small intestine disorder characterized by chronic inflammation, villus blunting, and impaired nutrient absorption. EED is prevalent in the same populations plagued by stunting, develops concurrently with loss in linear growth, and has explained upwards of 43% of observed growth faltering. EED has recently also been found in over 75% of children with moderate acute malnutrition (MAM, moderate wasting) in Sierra Leone, a population with high rates of deterioration to severe acute malnutrition and death, 20%. EED is a plausible cause for this treatment resistance, and for the high rates of recurrence seen in these children. There is an urgent need to increase understanding of the concurrence of stunting, EED, and wasting, and to test interventions targeted to their pathological underpinnings. Dietary egg can play a critical role in the fight against malnutrition by providing abundant high-quality protein and nutrients essential for physical and cognitive recovery. One egg/day has been shown to reduce stunting in several contexts. Recent evidence has shown that short-term egg/bovine colostrum supplement given to 9-12-month-old Malawian children improved linear growth and intestinal permeability in children with severe EED. It is possible that prolonged supplementation with egg in a high-risk population in rural Sierra Leone could improve acute and long-term health trajectories for children and put eggs on the map for food aid. This will be a randomized, investigator-blinded, controlled clinical trial testing whether daily supplementation with 15g whole egg powder during and for 18 weeks after treatment for moderate acute malnutrition might reduce intestinal permeability and improve linear growth, among other outcomes, when compared with control corn powder. Children with relatively higher risk MAM will be enrolled (MUAC \< 12.5 cm AND MUACz \< -2), treated with Supercereal Plus for up to 6 weeks, and undergo urine and stool collections at 6, 12, and 24 weeks. Urine collections will be for assessment of lactulose permeability and will involve participant consumption of a known amount of lactulose and collection of all urine over at least 4 hours thereafter. Stool collections will be for fecal host mRNA transcripts and selected proteins. Participants will also receive intermittent malaria chemoprophylaxis.
227 studies on the registry are indexed under Growth Disorders; 25 are open to participants now.
This study's enrollment of 461 is above the median of 413 across 143 interventional studies indexed under Growth Disorders.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
15g egg powder per day for 24 weeks
Dietary Supplement: Whole egg powder · Dietary Supplement: Supercereal Plus · Dietary Supplement: Micronutrient sprinkles · Drug: Sulfadoxine pyrimethamine
15g corn powder per day for 24 weeks
Dietary Supplement: Corn powder · Dietary Supplement: Supercereal Plus · Dietary Supplement: Micronutrient sprinkles · Drug: Sulfadoxine pyrimethamine
15g daily dose for 24 weeks
15g daily dose for 24 weeks
Approximately 110 g per day (1.5 kg every 2 weeks) supplementary food to be provided for treatment of MAM for up to 6 weeks.
To be provided after completion of MAM supplementary feeding. Provides 1 RDA of 14 micronutrients.
Infants \< 12 months of age: 250/12.5mg SP at enrollment, week 6, week 12, week 18. Infants \>= 12 months of age: 500/25mg SP at enrollment, week 6, week 12, week 18.
Also known as: SP
Percent lactulose excretion
Percent lactulose excretion in urine over \>=4 hours after lactulose consumption
Time frame: Collected 12 and 24 weeks after enrollment
Change in length-for-age z-score
Difference in length-for-age z-score between enrollment and weeks 12 and 24
Time frame: To be compared at 12 and 24 weeks after enrollment
Percent Lactulose excretion >= 0.2 and >=0.45
Proportion with moderately and severely abnormal small intestinal permeability. Percent lactulose excretion in urine over \>=4 hours after lactulose consumption
Time frame: Collected 6, 12, and 24 weeks after enrollment
Rate of length gain
mm/week
Time frame: Across 24 week follow-up period
LAZ < -2
Proportion stunted
Time frame: To be compared at 12, 18, and 24 weeks after enrollment
Fecal host mRNA transcripts
CD53, CDX1, HLA-DRA, TNF, S100A8, MUC12, and REG1A
Time frame: Collected 12 and 24 weeks after enrollment
Fecal host protein alpha-1 antitrypsin
Level of alpha-1 antitrypsin, mg/g
Time frame: Collected 12 and 24 weeks after enrollment
Fecal host protein myeloperoxidase
Level of myeloperoxidase, ng/mL
Time frame: Collected 12 and 24 weeks after enrollment
Fecal host protein neopterin
Level of neopterin, nmol/L
Time frame: Collected 12 and 24 weeks after enrollment
Rate of weight gain
g/kg/d
Time frame: Enrollment to week 6 (MAM treatment phase), and across 24 week follow-up period
Percent Lactulose excretion
Percent lactulose excretion in urine over \>=4 hours after lactulose consumption
Time frame: 6 weeks after enrollment
Deterioration to severe acute malnutrition
Mid-upper arm circumference \< 11.5 cm and/or nutritional edema
Time frame: Time-to-event across follow-up period
Recurrence of MAM
Development of MUAC \< 12.5 cm among those who achieved MUAC \>= 12.5 cm during initial MAM treatment
Time frame: Time-to-event across follow-up period
Sustained recovery
Defined by achievement mid-upper arm circumference \>= 12.5 cm without nutritional edema and maintenance of MUAC \>= 12.5 cm throughout follow-up thereafter.
Time frame: Across 24 week follow-up period
Death
As defined by caregiver report
Time frame: Time-to-event across follow-up period
Graduation
Defined by mid-upper arm circumference \>= 12.5 cm
Time frame: Within 6 weeks of enrollment
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Within 12 months of primary publication
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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