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OpenTrials
Completed

NCT Number: NCT00292812

Clinical Effects of a Nucleotides-Supplemented Infant Formula

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.

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Key information

Conditions

Nutritional Requirements

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soroka Medical Center

Beersheba, 84101, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy newborns aged 0-30 days.

Exclusion criteria

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

Treatment and study plan

Nutritional supplementation (nucleotides)

Drug

Primary outcomes

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

Secondary outcomes

  1. Side effects.

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Collaborators

  • Materna Laboratories

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Feb 16, 2006
Registry last updated
Oct 23, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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