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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03385252 |
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Date of registration:
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20/12/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Mazira Project: An Evaluation of Eggs During Complementary Feeding in Rural Malawi
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Scientific title:
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The Mazira Project: An Evaluation of Eggs During Complementary Feeding in Rural Malawi |
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Date of first enrolment:
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January 22, 2018 |
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Target sample size:
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662 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03385252 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Malawi
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Contacts
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Name:
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Kenneth M Maleta, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Malawi College of Medicine |
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Name:
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Christine P Stewart, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, Davis |
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Name:
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Chessa Lutter, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Maryland, College Park |
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Name:
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Lora Iannotti, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Washington University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Living in catchment area of Lungwena health center, Mangochi District, Malawi during
the study enrollment period
- Singleton birth
Exclusion Criteria:
- Egg allergy
- History of anaphylaxis or any serious allergic reaction requiring emergency medical
care
- Congenital or chronic condition impacting growth and development or ability to eat
eggs
- Severe anemia (hemoglobin < 5 g/dL)
- Mid-upper arm circumference < 12.5 cm or presence of bipedal edema
- Acute illness or injury warranting hospital referral
Age minimum:
6 Months
Age maximum:
9 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Infant Malnutrition
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Intervention(s)
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Behavioral: Visits
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Other: Eggs
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Primary Outcome(s)
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Stunting
[Time Frame: 6 months after the start of the intervention]
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Length-for-age z-score
[Time Frame: 6 months after the start of the intervention]
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Secondary Outcome(s)
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Plasma choline concentration
[Time Frame: 6 months after the start of the intervention]
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Cognitive development
[Time Frame: 6 months after the start of the intervention]
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Plasma amino acid concentrations
[Time Frame: 6 months after the start of the intervention]
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Weight-for-age z-score and prevalence of underweight (WAZ<-2)
[Time Frame: 6 months after the start of the intervention]
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Weight-for-length z-score and prevalence of wasting (WLZ<-2)
[Time Frame: 6 months after the start of the intervention]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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