Status:
COMPLETED
The Effects of Dietary Palmitic Acid Triacylglyceride Position on Bone Strength Parameters in Infants
Lead Sponsor:
Enzymotec
Conditions:
Personal Satisfaction
Eligibility:
All Genders
Up to 1 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on bone strength parameters.
Detailed Description
InFatTM is an advanced basic-fat ingredient, which mimics the fat composition and properties of human milk fat and enabling optimal intake of the essential calcium and energy (in the form of fatty aci...
Eligibility Criteria
Inclusion
- Gestational age above 32 weeks as determined by menstrual history and corroborated by prenatal US and/or physical examination.
- Birth weight appropriate for gestational age (AGA) using current CDC growth charts, and above 1750gr.
- The mother had unequivocally decided not to breast-feed (in formula groups) or the mother had decided to breast feed (in human breast milk group).
- The infant is apparently healthy.
- Parental/ legal guardian written inform consent
- Apgar after 5 minutes \>7
- Enrolled within their first 14 days of life for term infants and first month of life for preterm infants
- At enrollment: clinical stability and acceptable weight gain
Exclusion
- The infant suffer from a congenital or chromosomal disorder (Cystic fibrosis, Tracheomalacia, Tracheoesophageal fistula, major congenital heart disease, down-syndrome)
- The infant suffer from neonatal morbidities:
- Bronchopulmonary dysplasia (BPD)
- Intraventricular Hemorrhage3-4 (IVH)
- Necrotizing Enterocolitis (NEC)
- Laboratory or clinical sings of Osteopenia
- The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula)
- The mother suffers from any disease or disability that may interfere with her ability to take care of her infant
- Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00874068
Start Date
February 1 2009
End Date
December 1 2010
Last Update
February 24 2011
Active Locations (1)
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1
Meir Medical Center
Kfar Saba, Israel