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Docosaexahenoic Acid and Gross Motor Milestones in Infants

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ClinicalTrials.gov Identifier: NCT00610922
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : February 8, 2008
Sponsor:
Information provided by:
University of Milan

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Dietary Supplement: Docosahexaenoic acid (DHA) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: RCT of Supplemented Docosahexaenoic Acid and Gross Motor Development Milestones in Healthy Infants.
Study Start Date : May 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Doconexent

Arm Intervention/treatment
No Intervention: 1
Experimental: 2 Dietary Supplement: Docosahexaenoic acid (DHA)
DHA 20 mg per day through 12 months of life




Primary Outcome Measures :
  1. time of achieving the four gross motor development milestones [ Time Frame: 4, 8 and 12 months of age ]

Secondary Outcome Measures :
  1. time of achieving early fine motor milestones and language [ Time Frame: 4, 8 and 12 months of age ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610922


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

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
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: February 8, 2008
Last Verified: January 2008

Keywords provided by University of Milan:
Performance of motor skills