Docosaexahenoic Acid and Gross Motor Milestones in Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Group Type EXPERIMENTAL

Docosahexaenoic acid (DHA)

Intervention Type DIETARY_SUPPLEMENT

DHA 20 mg per day through 12 months of life

Interventions

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Docosahexaenoic acid (DHA)

DHA 20 mg per day through 12 months of life

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No