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OpenTrials
Completed

NCT Number: NCT00610922

Docosaexahenoic Acid and Gross Motor Milestones in 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.

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Key information

Conditions

Healthy

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Docosahexaenoic acid (DHA)

Dietary Supplement

DHA 20 mg per day through 12 months of life

Primary outcomes

  1. time of achieving the four gross motor development milestones

    Time frame: 4, 8 and 12 months of age

Secondary outcomes

  1. time of achieving early fine motor milestones and language

    Time frame: 4, 8 and 12 months of age

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

RCT of Supplemented Docosahexaenoic Acid and Gross Motor Development Milestones in Healthy Infants.

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Feb 8, 2008
Registry last updated
Feb 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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