Randomized, Controlled Trial - Lactoferrin Prevention of Diarrhea in Children
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ClinicalTrials.gov Identifier: NCT00560222 |
Recruitment Status
:
Completed
First Posted
: November 19, 2007
Last Update Posted
: November 1, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diarrhea Malnutrition | Dietary Supplement: bovine lactoferrin Dietary Supplement: placebo [maltodextrin] | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 555 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Randomized, Controlled Trial - Lactoferrin Prevention of Diarrhea in Children |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | May 2011 |
Actual Study Completion Date : | October 2011 |
Arm | Intervention/treatment |
---|---|
Active Comparator: A
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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Placebo Comparator: B
placebo
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Dietary Supplement: placebo [maltodextrin]
placebo that appears identical to lactoferrin will be given daily
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- Determination of 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. [ Time Frame: 6 months ]
- Determination of the effect of bovine lactoferrin supplementation on growth. [ Time Frame: 6 months ]

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Ages Eligible for Study: | 12 Months to 18 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Infants 12 to 18 months of age from the Outpatient clinics (Puestos de Salud) of Districto de Independencia in Lima, Peru will be eligible for enrollment in this study.
- Infants previously weaned for at least one week will be eligible for study.
Exclusion Criteria:
- Infants with either exclusive or partial breast-feeding will not be enrolled; mothers will be encouraged to continue breastfeeding.
- Infants ill with severe, persistent or chronic diarrhea will be excluded.
- Infants with severe malnutrition (defined as weight-for-height < -3 SDs, height-for-age < -3SDs)will be excluded.
- Infants with a serious infections that required hospitalization 1 month prior (e.g. meningitis,pneumonia, bacteremia) will be excluded.
- Infants with known HIV (data from parent or medical records) will be excluded.
- Infants with underlying chronic illness (e.g. malignancy, immunosuppression, chronic renal failure, congestive heart failure, liver failure) will be excluded.
- Infants with history of allergy to cow's milk or infant formula, eczema, allergic rhinitis or asthma will be excluded.
- Infants with a family history of eczema, allergic rhinitis, asthma, or milk intolerance will be excluded.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560222
Peru | |
Universidad Peruana Cayetana Heredia | |
Lima, Peru |
Principal Investigator: | Thomas G Cleary, MD | University of Texas School of Public Health - Houston |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Thomas G Cleary, Professor, Division of Epidemiology, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00560222 History of Changes |
Other Study ID Numbers: |
1R01HD051716-01A2 ( U.S. NIH Grant/Contract ) |
First Posted: | November 19, 2007 Key Record Dates |
Last Update Posted: | November 1, 2011 |
Last Verified: | October 2011 |
Keywords provided by Thomas G Cleary, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
randomized controlled trial lactoferrin children |
diarrhea malnutrition growth |
Additional relevant MeSH terms:
Diarrhea Malnutrition Signs and Symptoms, Digestive Signs and Symptoms |
Nutrition Disorders Lactoferrin Anti-Infective Agents |