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Docosaexahenoic Acid and Gross Motor Milestones in Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00610922
First Posted: February 8, 2008
Last Update Posted: February 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Milan
January 28, 2008
February 8, 2008
February 8, 2008
May 2005
December 2006   (Final data collection date for primary outcome measure)
time of achieving the four gross motor development milestones [ Time Frame: 4, 8 and 12 months of age ]
Same as current
No Changes Posted
time of achieving early fine motor milestones and language [ Time Frame: 4, 8 and 12 months of age ]
Same as current
Not Provided
Not Provided
 
Docosaexahenoic Acid and Gross Motor Milestones in Infants
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Healthy
Dietary Supplement: Docosahexaenoic acid (DHA)
DHA 20 mg per day through 12 months of life
  • No Intervention: 1
  • Experimental: 2
    Intervention: Dietary Supplement: Docosahexaenoic acid (DHA)
Agostoni C, Zuccotti GV, Radaelli G, Besana R, Podestà A, Sterpa A, Rottoli A, Riva E, Giovannini M. Docosahexaenoic acid supplementation and time at achievement of gross motor milestones in healthy infants: a randomized, prospective, double-blind, placebo-controlled trial. Am J Clin Nutr. 2009 Jan;89(1):64-70. doi: 10.3945/ajcn.2008.26590. Epub 2008 Dec 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1160
December 2006
December 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
up to 7 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00610922
NEON-02/2005-DHA
No
Not Provided
Not Provided
Prof. Carlo Agostoni, Dept of Pediatrics, San Paolo Hospital, University of Milan, Italy
University of Milan
Not Provided
Principal Investigator: Carlo Agostoni, Prof Dept. of Pediatrics, San Paolo Hospital, University of MIlan, Italy
University of Milan
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP