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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00560222 |
Much has been learned in recent years about the mechanisms by which breastfeeding improves child health and survival. However, there has been little progress in using these insights to improve pediatric care. Factors that are important for protecting the breast fed infant might be expected to decrease the adverse effects of weaning on diarrhea, growth, and development. The proposed study is meant to begin addressing this important gap by a clinical trial of lactoferrin supplementation in previously weaned children. Lactoferrin,an iron-binding protein with multiple physiological functions (anti-microbial, anti-inflammatory, and immunomodulatory), is one of the most important proteins present in mammalian milk. Our hypothesis is that lactoferrin (given as a daily supplement in amounts similar to those consumed if the child were still breastfed) will improve health by mimicking its protective roles in milk. The significance of these studies is that they will prove feasibility of improving child health after the end of breastfeeding by continuing ingestion of a major protective milk protein.
Diarrhea and malnutrition after weaning is a global problem that may be amenable to this approach.
Condition | Intervention | Phase |
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Diarrhea Malnutrition |
Dietary Supplement: bovine lactoferrin Dietary Supplement: placebo [maltodextrin] |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Controlled Trial - Lactoferrin Prevention of Diarrhea in Children |
Estimated Enrollment: | 602 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
This group will receive daily lactoferrin supplementation
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Dietary Supplement: bovine lactoferrin
1gm of lactoferrin will be given each day
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B: Placebo Comparator
placebo
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Dietary Supplement: placebo [maltodextrin]
placebo that appears identical to lactoferrin will be given daily
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The proposed community-based study will be conducted in a previously weaned population at risk for repeated intestinal infections. Infants who are 12-18 months of age living in the District of Independencia, Lima, Peru will be eligible for enrollment. We will conduct a randomized double blind placebo controlled trial comparing twice daily supplementation with bovine lactoferrin versus a placebo (maltodextrin) Therapy will be continued for 6 months with close monitoring of all study participants for diarrhea and growth.
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.
Ages Eligible for Study: | 12 Months to 18 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Thomas G Cleary, MD | 713 702 2860 | thomas.g.cleary@uth.tmc.edu |
Contact: Theresa J Ochoa, MD | theresa.j.ochoa@uth.tmc.edu |
Peru | |
Universidad Peruana Cayetana Heredia | Recruiting |
Lima, Peru | |
Contact: Elsa Chea, MD echea@upch.edu.pe | |
Contact: Theresa J Ochoa, MD Theresa.j.ochoa@uth.tmc.edu | |
Principal Investigator: Elsa Chea, MD |
Principal Investigator: | Thomas G Cleary, MD | University of Texas School of Public Health - Houston |
Responsible Party: | University of Texas School of Public Health ( Thomas Cleary/Professor ) |
Study ID Numbers: | 1 R01 HD051716-01A2, 1 R01 HD051716-01A2 |
Study First Received: | November 15, 2007 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00560222 History of Changes |
Health Authority: | United States: Federal Government |
randomized controlled trial lactoferrin children |
diarrhea malnutrition growth |
Signs and Symptoms Diarrhea Malnutrition Signs and Symptoms, Digestive Nutrition Disorders |
Signs and Symptoms Malnutrition Diarrhea Signs and Symptoms, Digestive Nutrition Disorders |