Clinical Effects of a Nucleotides-Supplemented Infant Formula

Soroka University Medical Center

Status: Completed

Conditions: Nutritional Requirements

Treatments: Drug: Nutritional supplementation (nucleotides)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00292812

Sor4123ctil

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 1 to 30 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy newborns aged 0-30 days.

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind