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NCT00292812 Clinical Trial

Clinical Effects of a Nucleotides-Supplemented Infant Formula

Nutritional Requirements Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00292812
Other study ID # Sor4123ctil
Secondary ID
Status Completed
Phase N/A
First received February 15, 2006
Last updated October 22, 2007
Start date March 2006
Est. completion date October 2007

Study information
Verified date May 2007
Source Soroka University Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 30 Days
Eligibility Inclusion Criteria:

- Healthy newborns aged 0-30 days.

Exclusion Criteria:

- Prematurity

- Chronic illness

- Failure to thrive

- Milk allergy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Nutritional supplementation (nucleotides)

Locations
Country Name City State
Israel Soroka Medical Center Beer-Sheva

Sponsors (2)
Lead Sponsor Collaborator
Soroka University Medical Center Materna Laboratories

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Growth percentiles, Behaviour and infantile colic, Bowel habits.
Secondary Side effects.
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