Randomized, Controlled Trial - Lactoferrin Prevention of Diarrhea in Children
NCT ID: NCT00560222
Last Updated: 2011-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
555 participants
INTERVENTIONAL
2008-02-29
2011-10-31
Brief Summary
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Detailed Description
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Specific aim 1: Determine the effect of bovine lactoferrin supplementation on prevention of diarrhea,measured by the number of episodes of diarrhea during a 6 month trial in previously weaned Peruvian children enrolled at 12 to 18 months of age.
Specific aim 2: Determine the effect of bovine lactoferrin supplementation on growth.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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A
This group will receive daily lactoferrin supplementation
bovine lactoferrin
1gm of lactoferrin will be given each day
B
placebo
placebo [maltodextrin]
placebo that appears identical to lactoferrin will be given daily
Interventions
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bovine lactoferrin
1gm of lactoferrin will be given each day
placebo [maltodextrin]
placebo that appears identical to lactoferrin will be given daily
Eligibility Criteria
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Inclusion Criteria
2. Infants previously weaned for at least one week will be eligible for study.
Exclusion Criteria
2. Infants ill with severe, persistent or chronic diarrhea will be excluded.
3. Infants with severe malnutrition (defined as weight-for-height \< -3 SDs, height-for-age \< -3SDs)will be excluded.
4. Infants with a serious infections that required hospitalization 1 month prior (e.g. meningitis,pneumonia, bacteremia) will be excluded.
5. Infants with known HIV (data from parent or medical records) will be excluded.
6. Infants with underlying chronic illness (e.g. malignancy, immunosuppression, chronic renal failure, congestive heart failure, liver failure) will be excluded.
7. Infants with history of allergy to cow's milk or infant formula, eczema, allergic rhinitis or asthma will be excluded.
8. Infants with a family history of eczema, allergic rhinitis, asthma, or milk intolerance will be excluded.
12 Months
18 Months
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Responsible Party
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Thomas G Cleary
Professor, Division of Epidemiology
Principal Investigators
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Thomas G Cleary, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas School of Public Health - Houston
Locations
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Universidad Peruana Cayetana Heredia
Lima, , Peru
Countries
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References
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