NCT00560222

Randomized, Controlled Trial - Lactoferrin Prevention of Diarrhea in Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 555 (actual)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: All
• Age: 12 Months – 18 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Diarrhea
• Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	bovine lactoferrin	1gm of lactoferrin will be given each day
DIETARY_SUPPLEMENT	placebo [maltodextrin]	placebo that appears identical to lactoferrin will be given daily

Timeline

• Start date: 2008-02-01
• Primary completion: 2011-05-01
• Completion: 2011-10-01
• First posted: 2007-11-19
• Last updated: 2011-11-01

Locations

1 site across 1 country: Peru