NCT00292812

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2006

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

October 23, 2007

Status Verified

May 1, 2007

First QC Date

February 15, 2006

Last Update Submit

October 22, 2007

Conditions

Nutritional Requirements

Keywords

Infant nutritionNucleotidesInfant formula

Outcome Measures

Primary Outcomes (1)

  • Growth percentiles, Behaviour and infantile colic, Bowel habits.

Secondary Outcomes (1)

  • Side effects.

Interventions

Nutritional supplementation (nucleotides)DRUG

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy newborns aged 0-30 days.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka Medical Center

Beersheba, 84101, Israel

Location

MeSH Terms

Interventions

Dietary SupplementsNucleotides

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesGlycosidesCarbohydratesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Zvi Weizman, MD

    Head, Pediatric GI and Nutrition Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2006

First Posted

February 16, 2006

Study Start

March 1, 2006

Study Completion

October 1, 2007

Last Updated

October 23, 2007

Record last verified: 2007-05

Locations

IL(1)