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Docosaexahenoic Acid and Gross Motor Milestones in Infants

This study has been completed.
Sponsor:
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT00610922
First received: January 28, 2008
Last updated: February 7, 2008
Last verified: January 2008
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Dietary Supplement: Docosahexaenoic acid (DHA)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: RCT of Supplemented Docosahexaenoic Acid and Gross Motor Development Milestones in Healthy Infants.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Milan:

Primary Outcome Measures:
  • time of achieving the four gross motor development milestones [ Time Frame: 4, 8 and 12 months of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time of achieving early fine motor milestones and language [ Time Frame: 4, 8 and 12 months of age ] [ Designated as safety issue: No ]

Enrollment: 1160
Study Start Date: May 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Experimental: 2 Dietary Supplement: Docosahexaenoic acid (DHA)
DHA 20 mg per day through 12 months of life

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610922

Sponsors and Collaborators
University of Milan
Investigators
Principal Investigator: Carlo Agostoni, Prof Dept. of Pediatrics, San Paolo Hospital, University of MIlan, Italy
  More Information

No publications provided by University of Milan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Carlo Agostoni, Dept of Pediatrics, San Paolo Hospital, University of Milan, Italy
ClinicalTrials.gov Identifier: NCT00610922     History of Changes
Other Study ID Numbers: NEON-02/2005-DHA
Study First Received: January 28, 2008
Last Updated: February 7, 2008
Health Authority: Italy : Institutional Review Board

Keywords provided by University of Milan:
Performance of motor skills

ClinicalTrials.gov processed this record on May 16, 2013