The Effects of Dietary Palmitic Acid Triacylglyceride Position on Bone Strength Parameters in Infants
NCT ID: NCT00874068
Last Updated: 2011-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
94 participants
INTERVENTIONAL
2009-02-28
2010-12-31
Brief Summary
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Detailed Description
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The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on bone strength parameters, anthropometric parameters, wellbeing and stool characteristics in term and preterm infants.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Standard vegetable oil formula
Standard vegetable oil based infant formula
standard vegetable oil based infant formula
InFat
InFat™ based infant formula
high sn-2 palmitic acid oil based infant formula
Breast-fed
No interventions assigned to this group
Interventions
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InFat™ based infant formula
high sn-2 palmitic acid oil based infant formula
Standard vegetable oil based infant formula
standard vegetable oil based infant formula
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Birth weight appropriate for gestational age (AGA) using current CDC growth charts, and above 1750gr.
3. 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).
4. The infant is apparently healthy.
5. Parental/ legal guardian written inform consent
6. Apgar after 5 minutes \>7
7. Enrolled within their first 14 days of life for term infants and first month of life for preterm infants
8. At enrollment: clinical stability and acceptable weight gain
Exclusion Criteria
2. The infant suffer from neonatal morbidities:
* Bronchopulmonary dysplasia (BPD)
* Intraventricular Hemorrhage3-4 (IVH)
* Necrotizing Enterocolitis (NEC)
3. Laboratory or clinical sings of Osteopenia
4. The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula)
5. The mother suffers from any disease or disability that may interfere with her ability to take care of her infant
6. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study
1 Month
ALL
Yes
Sponsors
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Enzymotec
INDUSTRY
Responsible Party
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Enzymotec
Principal Investigators
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Dan Nemet, MD
Role: PRINCIPAL_INVESTIGATOR
Meir Medical Center
Locations
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Meir Medical Center
Kfar Saba, , Israel
Countries
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References
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Litmanovitz I, Bar-Yoseph F, Lifshitz Y, Davidson K, Eliakim A, Regev RH, Nemet D. Reduced crying in term infants fed high beta-palmitate formula: a double-blind randomized clinical trial. BMC Pediatr. 2014 Jun 19;14:152. doi: 10.1186/1471-2431-14-152.
Other Identifiers
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PAL1
Identifier Type: -
Identifier Source: org_study_id
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