NCT00874068

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 24, 2011

Status Verified

February 1, 2011

Enrollment Period

1.8 years

First QC Date

March 31, 2009

Last Update Submit

February 23, 2011

Conditions

Personal Satisfaction

Keywords

term infantspreterm infantsbone strengthSpeed of sound (SOS)Ultrasound

Outcome Measures

Primary Outcomes (1)

  • bone strength parameters

    baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks

Secondary Outcomes (2)

  • stool characteristics

    baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks

  • Antropometric measurements

    baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks

Study Arms (3)

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

InFat™ based infant formulaOTHER

high sn-2 palmitic acid oil based infant formula

Also known as: high sn-2 palmitic acid, structured triglyceride
InFat
Standard vegetable oil based infant formulaOTHER

standard vegetable oil based infant formula

Also known as: standard vegetable oil
Standard vegetable oil formula

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

Related Publications (1)

  • 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.

    PMID: 24942975DERIVED

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Dan Nemet, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 2, 2009

Study Start

February 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 24, 2011

Record last verified: 2011-02

Locations

IL(1)