Clinical Effects of a Nucleotides-Supplemented Infant Formula

• Sponsor: Soroka University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00292812
• Collaborator: Materna Laboratories (Industry)
• Enrollment: 150
• Location: 1
• Duration (Months): 19
• Patients Per Site Per Month: 7.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nutritional Requirements	Drug: Nutritional supplementation (nucleotides)	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Prevention
• Official Title: The Clinical Effects of an Infant Formula Supplemented With Various Concentrations of Nucleotides
• Study Start Date: Mar 1, 2006
• Actual Study Completion Date: Oct 1, 2007

Outcome Measures

Primary Outcome Measures

1. Growth percentiles, Behaviour and infantile colic, Bowel habits. []

Secondary Outcome Measures

1. Side effects. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 30 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy newborns aged 0-30 days.

Exclusion Criteria:

• Prematurity

• Chronic illness

• Failure to thrive

• Milk allergy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soroka Medical Center	Beer-Sheva		Israel	84101

Sponsors and Collaborators

• Soroka University Medical Center
• Materna Laboratories

Investigators

• Principal Investigator: Zvi Weizman, MD, Head, Pediatric GI and Nutrition Unit

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00292812
• Other Study ID Numbers: Sor4123ctil
• First Posted: Feb 16, 2006
• Last Update Posted: Oct 23, 2007
• Last Verified: May 1, 2007

• Keywords provided by , ,: Infant nutrition; Nucleotides; Infant formula

Study Results

No Results Posted as of Oct 23, 2007