Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202306648724923 Date of Approval: 29/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Eggs for Gut Health
Official scientific title Egg to ameliorate environmental enteric dysfunction and improve linear growth in children with moderate acute malnutrition
Brief summary describing the background and objectives of the trial EED is defined by changes in the structure and function of the small intestinal mucosa seen in many people from rural, impoverished settings, particularly children under 5. The causes of EED remain unknown, though many of the same environmental factors tied to stunting have been tied to EED, including both dietary deficiencies and gastrointestinal infectious diseases. The macronutrient most lacking in typical diets of children who live in rural, impoverished settings worldwide is high-quality protein, particularly in children with EED. Eggs are considered a perfect source of protein, with an amino acid profile against which other proteins are compared. Eggs thus provide the high-quality protein children with moderate wasting, stunting, and EED require to heal the gut and promote linear and ponderal growth. Broad Objective: To provide MoH and international agencies with evidence of egg’s effect on gut permeability, linear growth, and fecal mRNA profile among children with MAM. Specific Objective: To determine the effects of a daily ration of powdered egg on intestinal permeability and linear growth after 6, 12, and 24 weeks among children with moderate acute malnutrition (MAM) in Sierra Leone as compared with corn powder. Intestinal permeability will be determined by % urinary lactulose excretion after receiving an oral dose of lactulose. Linear growth will be expressed as a change in length-for-age z-score. Secondary aims include determining the effect of daily powdered egg on selected fecal host mRNA transcripts and proteins (alpha-1 antitrypsin, myeloperoxidase, neopterin, CD53, CDX1, HLA-DRA, TNF, S100A8, MUC12, and REG1A), rate of weight gain, rates of deterioration to severe acute malnutrition or death, and rates of recurrence of acute malnutrition over the 24 weeks of enrolment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 10/07/2023
Actual trial start date 09/10/2023
Anticipated date of last follow up 31/12/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
030052023 Sierra Leone Ethics and Scientific Review Committee
202306090 Washington University Institutional Review Board
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Corn Powder 15g daily plus 1 packet daily of micronutrient powder 24 weeks Daily dose of 15g Corn powder. After MAM treatment complete, will also receive 1 packet/day of micronutrient powder providing about 1 RDA of 14 micronutrients. Will also receive SP+AQ malaria chemoprophylaxis every 6 weeks. For children < 12 months old, 250/12.5 mg SP once + 75 mg AQ for three days every 6 weeks. For children >= 12 months old, 500/25 mg SP once + 150 mg AQ for three days every 6 weeks. 200 Active-Treatment of Control Group
Experimental Group Whole Egg Powder 15 g daily of whole egg powder plus 1 packet/day of micronutrient powder 24 weeks Whole Hen Egg Powder 15g per day. Once MAM treatment complete, participants will also receive1 packet/day of micronutrient powder providing about 1 RDA of 14 micronutrients. Will also receive SP+AQ malaria chemoprophylaxis every 6 weeks. For children < 12 months old, 250/12.5 mg SP once + 75 mg AQ for three days every 6 weeks. For children >= 12 months old, 500/25 mg SP once + 150 mg AQ for three days every 6 weeks. 200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
At least 6 months of age and less than 30 months of age Mid-upper arm circumference < 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 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 Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 6 Month(s) 30 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/05/2023 Sierra Leone Ethics and Scientific Review Committee
Ethics Committee Address
Street address City Postal code Country
5th Floor, Youyi Building Brookfields Freetown NA Sierra Leone
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Percent lactulose (% L) excretion at 12 and 24 weeks 6, 12 and 24 weeks
Primary Outcome Change in length-for-age z-score after 12 and 24 weeks 0, 12 and 24 weeks
Secondary Outcome Host fecal mRNA transcription profile 6, 12, and 24 weeks
Secondary Outcome Proportion of children with no vs. severe (%L > 0.45) EED 6,12, 24 weeks
Secondary Outcome Proportion stunted 0, 2, 4, 6, 12, 18, 24 weeks
Secondary Outcome Percent lactulose excretion at 6 weeks 6 weeks
Secondary Outcome Rate of length gain 0, 2, 4, 6, 12, 18, 24 weeks
Secondary Outcome Deterioration to severe acute malnutrition or death 0, 2, 4, 6, 12, 18, 24 weeks
Secondary Outcome Rate of weight gain 0, 2, 4, 6, 12, 18, 24 weeks
Secondary Outcome Recurrence of MAM 12, 18, 24 weeks
Secondary Outcome Fecal protein markers AAT, MPO, NEO 6, 12, and 24 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bandajuma Health Center Medical Stores Drive Pujehun Sierra Leone
Gbendapi Health Center NA NA Sierra Leone
Taninahuh Health Center NA NA Sierra Leone
Jendema Health Center NA NA Sierra Leone
Hongai Health Center NA NA Sierra Leone
Static Health Center NA NA Sierra Leone
Portaru Health Center NA NA Sierra Leone
Blama Health Center NA NA Sierra Leone
Zimi Health Center NA NA Sierra Leone
Gofer Health Center NA NA Sierra Leone
FUNDING SOURCES
Name of source Street address City Postal code Country
Thrasher Research Fund 68 S Main Street, Suite 400 Salt Lake City 84101 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Washington University in St. Louis 1 Brookings Drive Saint Louis 63130 United States of America University
COLLABORATORS
Name Street address City Postal code Country
Sierra Leone Ministry of Health and Sanitation 4th and 5th floors, Youyi Building Freetown Sierra Leone
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mark Manary manarymj@wustl.edu +13144542341 600 South Euclid Aveune
City Postal code Country Position/Affiliation
Saint Louis 63110 United States of America Professor of Pediatrics
Role Name Email Phone Street address
Public Enquiries Donna Wegner donnarwegner@wustl.edu +13144547162 600 South Euclid
City Postal code Country Position/Affiliation
Saint Louis 63110 United States of America Senior Grant Specialist in Department of Pediatrics
Role Name Email Phone Street address
Scientific Enquiries Kevin Stephenson k.stephenson@wustl.edu +3144545685 600 South Taylor Avenue, Suite 155
City Postal code Country Position/Affiliation
Saint Louis 63110 United States of America Instructor of Medicine
Role Name Email Phone Street address
Scientific Enquiries Aminata Koroma shamitamin@gmail.com +23276300770 Jomo Kenyatta Road
City Postal code Country Position/Affiliation
Freetown Sierra Leone Director of Food and Nutrition in the Sierra Leone Ministry of Health and Sanitation
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data will be available. All of the individual participant data collected during the trial will be shared, after deidentification. The study protocol, statistical analysis plan, informed consent form, and analytic code will be shared. The data will be available within 12 months of the primary trial publication. Anyone who wishes to access the data will have access, for any type of analysis purpose. The data will be posted on a public repository. Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months of primary trial publication None
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information