Docosaexahenoic Acid and Gross Motor Milestones in Infants
RCT of Supplemented Docosahexaenoic Acid and Gross Motor Development Milestones in Healthy Infants.
1 other identifier
interventional
1,160
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started May 2005
Typical duration for not_applicable healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 28, 2008
CompletedFirst Posted
Study publicly available on registry
February 8, 2008
CompletedFebruary 8, 2008
January 1, 2008
1.6 years
January 28, 2008
February 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time of achieving the four gross motor development milestones
4, 8 and 12 months of age
Secondary Outcomes (1)
time of achieving early fine motor milestones and language
4, 8 and 12 months of age
Study Arms (2)
1
NO INTERVENTION2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Agostoni C, Zuccotti GV, Radaelli G, Besana R, Podesta 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.
PMID: 19056592DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlo Agostoni, Prof
Dept. of Pediatrics, San Paolo Hospital, University of MIlan, Italy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 28, 2008
First Posted
February 8, 2008
Study Start
May 1, 2005
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
February 8, 2008
Record last verified: 2008-01