Healthy
Conditions
Keywords
Performance of motor skills
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.
Interventions
DIETARY_SUPPLEMENTDocosahexaenoic acid (DHA)
DHA 20 mg per day through 12 months of life
Sponsors
University of Milan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 7 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time of achieving the four gross motor development milestones | 4, 8 and 12 months of age |
Secondary
| Measure | Time frame |
|---|---|
| time of achieving early fine motor milestones and language | 4, 8 and 12 months of age |
Outcome results
None listed