Clinical Effects of a Nucleotides-Supplemented Infant Formula

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-10-31

Brief Summary

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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

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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.

Conditions

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Nutritional Requirements

Keywords

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Infant nutrition Nucleotides Infant formula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Nutritional supplementation (nucleotides)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy newborns aged 0-30 days.

Exclusion Criteria

* Prematurity
* Chronic illness
* Failure to thrive
* Milk allergy

Minimum Eligible Age

1 Day

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Zvi Weizman, MD

Role: PRINCIPAL_INVESTIGATOR

Head, Pediatric GI and Nutrition Unit

Locations

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Soroka Medical Center

Beersheba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Sor4123ctil

Identifier Type: -

Identifier Source: org_study_id