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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

January 28, 2008
February 7, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00610922 on ClinicalTrials.gov Archive Site
time of achieving early fine motor milestones and language [ Time Frame: 4, 8 and 12 months of age ] [ Designated as safety issue: No ]
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: Double Blind (Subject, Caregiver, 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. 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.
Both
up to 7 Days
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00610922
NEON-02/2005-DHA
No
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