Effects of Different ARA Formulations of Infant Formula on Fatty Acid Status, Immune Markers and Infection Rates in Infants
EFFECTS OF DIFFERENT ARA FORMULATIONS OF INFANT FORMULA ON FATTY ACID STATUS, IMMUNE MARKERS AND INFECTION RATES IN INFANTS
1 other identifier
interventional
110
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2016
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 3, 2017
CompletedFirst Posted
Study publicly available on registry
January 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedJanuary 18, 2020
January 1, 2020
2.5 years
January 3, 2017
January 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
total plasma fatty acid ARA levels
difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation
6 months of supplementation
Secondary Outcomes (6)
incidence of infections
6 months of supplementation
weight gain
6 months of supplementation
length gain
6 months of supplementation
head circumference
6 months of supplementation
dietary intake of ARA
6 months of supplementation
- +1 more secondary outcomes
Study Arms (2)
combination ARA+ DHA
ACTIVE COMPARATORcombination 0.76% ARA+ 0.4% DHA in infant formula per day
DHA
EXPERIMENTAL0% ARA +0.4% DHA in infant formula per day
Interventions
combination ARA + DHA supplemented infant formula
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DSM Nutritional Products, Inc.lead
- SynteractHCRcollaborator
Study Sites (2)
Centro de Salud Aravaca
Madrid, Spain
Centro Salud Arganda del Rey
Madrid, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ascension Marcos, PhD
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2017
First Posted
January 9, 2017
Study Start
November 1, 2016
Primary Completion
May 1, 2019
Study Completion
August 1, 2019
Last Updated
January 18, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share