CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 555 enrolled
Drug / intervention
bovine lactoferrin +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00560222
NCT00560222Phase 3Completed

Randomized, Controlled Trial - Lactoferrin Prevention of Diarrhea in Children

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·interventional·Posted Nov 19, 2007·Updated Nov 1, 2011

In Brief

A Phase 3 clinical trial evaluating bovine lactoferrin and placebo [maltodextrin] for Diarrhea and Malnutrition. Completed, enrolled 555 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPeru
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 19, 2007
Enrollment StartFeb 1, 2008
Primary CompletionMay 1, 2011
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.6 years ago

Interventions

bovine lactoferrindietary

1gm of lactoferrin will be given each day

placebo [maltodextrin]dietary

placebo that appears identical to lactoferrin will be given daily