The Effects of Dietary Palmitic Acid Triacylglyceride Pos... | NCT00874068

Studies
The Effects of Dietary Palmitic Acid Triacylglyceride Position on Bone Strength Parameters in Infants

NCT00874068

Sponsor

Enzymotec

Status

Completed

Last Update Posted

Feb 24, 2011Estimated

Enrollment

94Actual

Phase

Not Applicable

Conditions

Personal Satisfaction

Interventions

InFat™ based infant formula
Standard vegetable oil based infant formula

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Mar 31, 2009

First Submission Date that Met QC Criteria

Apr 1, 2009

First Posted Date

Apr 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2011

Last Update Posted Date

Feb 24, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 acids) and easy digestion. These benefits are the results of a unique fatty acid composition on the glycerol backbone, which ensure high level of palmitic acid at the middle (sn-2) position.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

94Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Standard vegetable oil formula	Active Comparator	Other: Standard vegetable oil based infant formula
InFat	Active Comparator	Other: InFat™ based infant formula
Breast-fed	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
InFat™ based infant formula	Other	high sn-2 palmitic acid oil based infant formula	InFat

Measure	Description	Time Frame
bone strength parameters		baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks

Measure	Description	Time Frame
stool characteristics		baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks
Antropometric measurements		baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

1 Month

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Dan Nemet, MD	Meir Medical Center	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24942975	Derived	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.