An interventional study of combination ARA + DHA and DHA in Healthy Infants, sponsored by DSM Nutritional Products, Inc.. Completed at 2 sites in Spain. Open to participants aged 22 Weeks to 26 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by DSM Nutritional Products, Inc. · Not applicable, Interventional, and Treatment
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 110 is close to the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →DSM Nutritional Products, Inc. is the lead sponsor of 37 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
combination 0.76% ARA+ 0.4% DHA in infant formula per day
Dietary Supplement: combination ARA + DHA
0% ARA +0.4% DHA in infant formula per day
Dietary Supplement: DHA
combination ARA + DHA supplemented infant formula
Also known as: infant formula
DHA supplemented infant formula
Also known as: infant formula
total plasma fatty acid ARA levels
difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation
Time frame: 6 months of supplementation
incidence of infections
record number, type and duration of infections
Time frame: 6 months of supplementation
weight gain
differences between groups in weight gain (kg/d)
Time frame: 6 months of supplementation
length gain
differences between groups in length gain (cm/d)
Time frame: 6 months of supplementation
head circumference
differences between groups in head circumference (cm/d)
Time frame: 6 months of supplementation
dietary intake of ARA
24 hour recall questionnaire
Time frame: 6 months of supplementation
plasma levels of immune markers
cytokines and T cells levels in plasma will be measured
Time frame: 6 months of supplementation
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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DSM Nutritional Products, Inc.