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Docosaexahenoic Acid and Gross Motor Milestones in Infants

NCT00610922 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1160

Last updated 2008-02-08

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Docosahexaenoic acid (DHA)

DHA 20 mg per day through 12 months of life

Sponsors & Collaborators

  • University of Milan

    lead OTHER

Principal Investigators

  • Carlo Agostoni, Prof · Dept. of Pediatrics, San Paolo Hospital, University of MIlan, Italy

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2006-12-31
Completion
2006-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00610922 on ClinicalTrials.gov