Status:
COMPLETED
Evaluation of the Effect of Pure Canterbury Stage 1 Infant Formula Milk Powder on the Growth of Infant 0-6 Months of Age
Lead Sponsor:
Bright Dairy & Food Co., Ltd
Conditions:
Growth Acceleration
Eligibility:
All Genders
7-90 years
Phase:
PHASE4
Brief Summary
This was a randomized, double-blind, single-center, placebo-controlled, three-arm study, with a 12-week intervention period. The objectives of this study were to evaluate the effect of Pure Canterbur...
Detailed Description
• Quality control of the study: 1.1 Study monitoring and source data verification: Monitoring was done according to the monitoring plan by a representative of the investigator, who checked the case re...
Eligibility Criteria
Inclusion
- Infants 7\~90 days old;
- Fed by breast milk before enrollment;
- Concent form signed by parents
Exclusion
- Twins, multiple births, low birth weight children, over birth weight children or early birth children with gestational age less than 37 weeks;
- During pregnancy, the mothers had pregnancy complications or other disease that may affect the study results;
- Having serious diseases that may affect study interventions, such as neonatal sepsis, pneumonia (associated with respiratory failure), heart failure and other diseases;
- Having neonatal diarrhea or acute respiratory infections within 48 hours before enrollment;
- Having potential metabolic diseases, chronic diseases, congenital malformations, central nervous system disorders, neuromuscular disorders or diseases affecting bone metabolism that may affect growth or the study results;
- Having taken any food containing prebiotics or probiotics within 15 days of enrollment;
- Having gluten allergy (celiac disease);
- Body weight-to-height Z-value \<-3 according to the standard of WHO;
- Receiving hormone therapy and intravenous nutrition;
- Lactose intolerance;
- Have participated in other clinical studies within 3 months prior to the date of screening;
- Unable to comply the study schedule
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02239588
Start Date
April 1 2014
End Date
July 1 2014
Last Update
September 15 2014
Active Locations (1)
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1
XinHua Hospital Affiliated to Shanghai JiaoTong University
Shanghai, China