Docosaexahenoic Acid and Gross Motor Milestones in Infants

February 7, 2008 updated by: University of Milan

RCT of Supplemented Docosahexaenoic Acid and Gross Motor Development Milestones in Healthy Infants.

To examine whether daily supplement of docosahexaenoic acid throughout the first year of life may speed up the achievement of gross motor development milestones in healthy infants, a total of 1160 healthy infants randomly allocated to receive throughout the first year of life daily oral supplement of vitamin D3 (400 IU) plus docosahexaenoic acid (20 mg) or vitamin D3 (400 IU) alone. Primary outcome measure: time of achieving gross motor development milestones. Secondary outcome measure: time of achieving early fine motor development milestones and language.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1160

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • weight at birth equal or above 2500 g;
  • gestational age between 37 and 42 completed weeks;
  • single birth;
  • absence of neonatal or birth abnormalities;
  • Apgar score greater than or equal to 7 at 5 m;
  • white parents.

Exclusion Criteria:

  • presence of neonatal diseases requiring hospitalisation for longer than 7 days;
  • unknown father;
  • parents unable to understand the protocol requirements and to fill out the infants diary;
  • infant already enrolled or selected for another clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Dietary supplement: Docosahexaenoic acid (DHA)
DHA 20 mg per day through 12 months of life
No Intervention: 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time of achieving the four gross motor development milestones
Time Frame: 4, 8 and 12 months of age
4, 8 and 12 months of age

Secondary Outcome Measures

Outcome Measure
Time Frame
time of achieving early fine motor milestones and language
Time Frame: 4, 8 and 12 months of age
4, 8 and 12 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Investigators

  • Principal Investigator: Carlo Agostoni, Prof, Dept. of Pediatrics, San Paolo Hospital, University of MIlan, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

January 28, 2008

First Submitted That Met QC Criteria

February 7, 2008

First Posted (Estimate)

February 8, 2008

Study Record Updates

Last Update Posted (Estimate)

February 8, 2008

Last Update Submitted That Met QC Criteria

February 7, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NEON-02/2005-DHA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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