Docosaexahenoic Acid and Gross Motor Milestones in Infants

University of Milan1,160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

1,160

Conditions

Healthy

Interventions

Docosahexaenoic acid (DHA)DIETARY_SUPPLEMENT

DHA 20 mg per day through 12 months of life

Eligibility

Sex: ALLMin age: 1 DayMax age: 7 Days

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

time of achieving the four gross motor development milestones

Time frame: 4, 8 and 12 months of age

Secondary Outcomes

time of achieving early fine motor milestones and language

Time frame: 4, 8 and 12 months of age

Data from ClinicalTrials.gov

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