Clinical Effects of a Nucleotides-Supplemented Infant Formula

Soroka University Medical Center150 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

150

Conditions

Nutritional Requirements

Interventions

Nutritional supplementation (nucleotides)DRUG

Eligibility

Sex: ALLMin age: 1 DayMax age: 30 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy newborns aged 0-30 days. Exclusion Criteria: * Prematurity * Chronic illness * Failure to thrive * Milk allergy

Locations (1)

Soroka Medical Center

Beersheba, Israel

Outcomes

Primary Outcomes

Growth percentiles, Behaviour and infantile colic, Bowel habits.

Secondary Outcomes

Side effects.

Data from ClinicalTrials.gov

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