Clinical Effects of a Nucleotides-Supplemented Infant For... | NCT00292812

Studies
Clinical Effects of a Nucleotides-Supplemented Infant Formula

NCT00292812

Sponsor

Soroka University Medical Center

Status

Completed

Last Update Posted

Oct 23, 2007Estimated

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Nutritional Requirements

Interventions

Nutritional supplementation (nucleotides)

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

May 2007

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

Mar 2006

Primary Completion Date

Not provided

Completion Date

Oct 2007Actual

First Submitted Date

Feb 15, 2006

First Submission Date that Met QC Criteria

Feb 15, 2006

First Posted Date

Feb 16, 2006Estimated

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

Oct 22, 2007

Last Update Posted Date

Oct 23, 2007Estimated

Name	Class
Materna Laboratories	INDUSTRY

Description Module

Brief Summary

The study hypothesis is that different concentrations of nucleotides' supplementation of an infant formula might affect differently growth and/or other clinical parameters in neonates.

Detailed Description

Three groups of 50 newborn infants each, will be fed for 30 days an infant formula supplemented with either 4.9 mg/100 kcal or 10.6 mg/100 kcal of nucleotides or with no supplementation. Newborns will be monitored prospectively for the following outcome parameters:

Growth percentiles.
Behaviour and infantile colic.
Bowel habits.
Side effects.

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

150Estimated

Name	Type	Description	Arm Group Labels	Other Names
Nutritional supplementation (nucleotides)	Drug

Measure	Description	Time Frame
Growth percentiles, Behaviour and infantile colic, Bowel habits.

Measure	Description	Time Frame
Side effects.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy newborns aged 0-30 days.

Exclusion Criteria:

Prematurity
Chronic illness
Failure to thrive
Milk allergy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

30 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zvi Weizman, MD	Head, Pediatric GI and Nutrition Unit	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soroka Medical Center		Beersheba		84101	Israel

Intervention Browse Module

MeSH Terms

ID	Term
D019587	Dietary Supplements
D009711	Nucleotides

Ancestor Terms

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided