Healthy Infants
Conditions
Keywords
arachidonic, docosahexaenoic acid, infant formula
Brief summary
The clinical trial will investigate the effect of different formulations of ARA + 0.4% DHA in infant formula on plasma fatty acid status in healthy 6 months old infants supplemented for 6 months. A 6-month follow on phase will provide additional efficacy (e.g. infection rates, immune markers) and safety information in these 12-18 month old infants.
Detailed description
This study is a randomized, double-blind, parallel-group study of 0% ARA +0.4% DHA or 0.76% ARA +0.4% DHA supplemented infant formula provided to 6 months old healthy infants for 6 months. Infants will have been breast-fed or formula-fed prior to enrollment. The difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation will be measured. Parents will be asked about the infant's current daily diet (fatty acid intakes calculated via 24 hour recalls). All completed infants will be enrolled into a 6 month extension period (non-supplemented) to collect additional measures of efficacy (i.e. infections and illnesses, immune markers) and safety out to 18 months of age.
Interventions
DIETARY_SUPPLEMENTcombination ARA + DHA
combination ARA + DHA supplemented infant formula
DIETARY_SUPPLEMENTDHA
DHA supplemented infant formula
Sponsors
SynteractHCR
DSM Nutritional Products, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Weeks to 26 Weeks
Healthy volunteers
Yes
Inclusion criteria
* singleton infants, * parent of legal age to consent, * willing to feed the child the assigned study formula for the treatment duration, * parent agrees to scheduled blood draws
Exclusion criteria
* exclusively breastfed or formula-fed beyond 6 months, * difficulty swallowing or other congenital malformation or metabolic anomaly, * taking omega-3 (supplemented) foods, * mother had gestational diabetes or is Type II diabetic, * born at \<37 weeks gestational age, * participating in another study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total plasma fatty acid ARA levels | 6 months of supplementation | difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| weight gain | 6 months of supplementation | differences between groups in weight gain (kg/d) |
| length gain | 6 months of supplementation | differences between groups in length gain (cm/d) |
| incidence of infections | 6 months of supplementation | record number, type and duration of infections |
| dietary intake of ARA | 6 months of supplementation | 24 hour recall questionnaire |
| plasma levels of immune markers | 6 months of supplementation | cytokines and T cells levels in plasma will be measured |
| head circumference | 6 months of supplementation | differences between groups in head circumference (cm/d) |
Countries
Spain
Outcome results
None listed