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Moderate Acute MalnutritionNCT06002438

Eggs for Gut Health

A study testing Whole egg powder, Corn powder and Supercereal Plus in people with Moderate Acute Malnutrition and Stunting, run by Washington University School of Medicine at 10 sites in Sierra Leone.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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: Will provision of 15g of whole egg powder per day during and after treatment for moderate acute malnutrition (for 24 weeks total) improve small… Read more about this study

Who is it for?
Ages 6 to 30 months
What is being tested?
Whole egg powder, Corn powder and Supercereal Plus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
461 participants
Where
10 sitesSierra Leone
Study dates
9 Oct 2023to 19 Dec 2024
Phase
Interventional
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 6 to 30 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • At least 6 months of age and less than 30 months of age
  • Mid-upper arm circumference >= 11.5cm and < 12. 5 cm
  • Mid-upper arm circumference-for-age z-score < -2
  • Provision of signed (or thumb-printed) and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating clinic

Who cannot join

  • Nutritional edema
  • Simultaneous involvement in another research trial or supplementary feeding program
  • Chronic debilitating illness
  • Allergy to egg
  • Receipt of treatment for acute malnutrition within 1 month prior to screening

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Sierra Leone10 sites
  • Bandajuma

    Bandajuma, Southern Province

  • Bendu Maleh

    Bendu, Southern Province

  • Blama Massaquoi

    Blama Massaquoi, Southern Province

  • Gbondapi

    Gbondapi, Southern Province

  • Gofor

    Gofor, Southern Province

  • Jendema

    Jendema, Southern Province

  • Potoru

    Potoru, Southern Province

  • Pujehun Static

    Pujehun, Southern Province

  • Taninahun

    Taninahun, Southern Province

  • Zimmi

    Zimmi, Southern Province

Other trials in Sierra Leone

About this study

Official title: Egg to Ameliorate Environmental Enteric Dysfunction and Improve Growth in Children With Moderate Acute Malnutrition

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:

  • Will provision of 15g of whole egg powder per day during and after treatment for moderate acute malnutrition (for 24 weeks total) improve small intestinal permeability and linear growth among 6-30 month old Sierra Leonean children compared with daily corn powder supplementation?
Read the detailed description

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.

Being tested
Whole egg powder, Corn powder, Supercereal Plus, Micronutrient sprinkles, Sulfadoxine pyrimethamine
Medical subject headings
Growth Disorders, Severe Acute Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole egg powderDietary supplement

    15g daily dose for 24 weeks

  • Corn powderDietary supplement

    15g daily dose for 24 weeks

  • Supercereal PlusDietary supplement

    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.

  • Micronutrient sprinklesDietary supplement

    To be provided after completion of MAM supplementary feeding. Provides 1 RDA of 14 micronutrients.

  • Sulfadoxine pyrimethamineDrug

    Also called SP

    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.

Study groups in NCT06002438
Study groupRoleWhat they receive
Egg powderExperimental15g egg powder per day for 24 weeks
Receives: Dietary Supplement: Whole egg powder; Dietary Supplement: Supercereal Plus; Dietary Supplement: Micronutrient sprinkles; Drug: Sulfadoxine pyrimethamine
Corn powderActive comparator15g corn powder per day for 24 weeks
Receives: Dietary Supplement: Corn powder; Dietary Supplement: Supercereal Plus; Dietary Supplement: Micronutrient sprinkles; Drug: Sulfadoxine pyrimethamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent lactulose excretion

    Percent lactulose excretion in urine over >=4 hours after lactulose consumption

    Measured: Collected 12 and 24 weeks after enrollment

  2. Change in length-for-age z-score

    Difference in length-for-age z-score between enrollment and weeks 12 and 24

    Measured: To be compared at 12 and 24 weeks after enrollment

Secondary outcomes (14)
  1. 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

    Measured: Collected 6, 12, and 24 weeks after enrollment

  2. Rate of length gain

    mm/week

    Measured: Across 24 week follow-up period

  3. LAZ < -2

    Proportion stunted

    Measured: To be compared at 12, 18, and 24 weeks after enrollment

  4. Fecal host mRNA transcripts

    CD53, CDX1, HLA-DRA, TNF, S100A8, MUC12, and REG1A

    Measured: Collected 12 and 24 weeks after enrollment

  5. Fecal host protein alpha-1 antitrypsin

    Level of alpha-1 antitrypsin, mg/g

    Measured: Collected 12 and 24 weeks after enrollment

  6. Fecal host protein myeloperoxidase

    Level of myeloperoxidase, ng/mL

    Measured: Collected 12 and 24 weeks after enrollment

  7. Fecal host protein neopterin

    Level of neopterin, nmol/L

    Measured: Collected 12 and 24 weeks after enrollment

  8. Rate of weight gain

    g/kg/d

    Measured: Enrollment to week 6 (MAM treatment phase), and across 24 week follow-up period

  9. Percent Lactulose excretion

    Percent lactulose excretion in urine over >=4 hours after lactulose consumption

    Measured: 6 weeks after enrollment

  10. Deterioration to severe acute malnutrition

    Mid-upper arm circumference < 11.5 cm and/or nutritional edema

    Measured: Time-to-event across follow-up period

  11. Recurrence of MAM

    Development of MUAC < 12.5 cm among those who achieved MUAC >= 12.5 cm during initial MAM treatment

    Measured: Time-to-event across follow-up period

  12. 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.

    Measured: Across 24 week follow-up period

  13. Death

    As defined by caregiver report

    Measured: Time-to-event across follow-up period

  14. Graduation

    Defined by mid-upper arm circumference >= 12.5 cm

    Measured: Within 6 weeks of enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start9 Oct 2023
  3. Primary completion19 Dec 2024
  4. Study completion19 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
461 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06002438
Sponsor's protocol ID
202306090
Status last verified
Feb 2025
First submitted
10 Aug 2023
Last updated
6 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Stephenson KB, Greenfeld A, Ryan MG, Kleban E, Kwak L, Lee A, Wegner DR, Jiang X, Hendrixson DT, Kamara MT, Koroma AS, Manary MJ. Egg supplementation for 24 weeks does not improve linear growth or reduce small intestinal permeability in Sierra Leonean children with moderate wasting: a randomized, blinded, controlled trial. Am J Clin Nutr. 2025 Nov;122(5):1326-1337. doi: 10.1016/j.ajcnut.2025.08.019. Epub 2025 Oct 14.

    PubMed 41193034

Questions about this trial

What is this clinical trial studying?

A study testing Whole egg powder, Corn powder and Supercereal Plus in people with Moderate Acute Malnutrition and Stunting, run by Washington University School of Medicine at 10 sites in Sierra Leone.

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 5 inclusion and 5 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 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Sierra Leone. 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?

Percent lactulose excretion (time frame: Collected 12 and 24 weeks after enrollment). 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?

On the ClinicalTrials.gov record for NCT06002438, which also lists 1 linked publication.

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 6 Feb 2025.

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