Clinical Effects of a Nucleotides-Supplemented Infant Formula

The Clinical Effects of an Infant Formula Supplemented With Various Concentrations of Nucleotides

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00292812

Enrollment

150

Registered

2006-02-16

Start date

2006-03-31

Completion date

2007-10-31

Last updated

2007-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional Requirements

Keywords

Infant nutrition, Nucleotides, Infant formula

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.

Interventions

DRUGNutritional supplementation (nucleotides)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

1 Days to 30 Days

Healthy volunteers

Yes

Inclusion criteria

* Healthy newborns aged 0-30 days.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Growth percentiles, Behaviour and infantile colic, Bowel habits.	—

Secondary

Measure	Time frame
Side effects.	—

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026