Healthy InfantsNCT03014115
Effects of Different ARA Formulations of Infant Formula on Fatty Acid Status, Immune Markers and Infection Rates in Infants
A study testing combination ARA + DHA and DHA in people with Healthy Infants, run by dsm-firmenich Switzerland AG at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 26 weeksHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- combination ARA + DHA and DHA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesSpain
- Study dates
- Nov 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 26 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: EFFECTS OF DIFFERENT ARA FORMULATIONS OF INFANT FORMULA ON FATTY ACID STATUS, IMMUNE MARKERS AND INFECTION RATES IN INFANTS
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.
Read the 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.
- Conditions
- Healthy Infants
- Being tested
- combination ARA + DHA, DHA
- Keywords
- arachidonic, docosahexaenoic acid, infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination ARA + DHADietary supplement
Also called infant formula
combination ARA + DHA supplemented infant formula
DHADietary supplement
Also called infant formula
DHA supplemented infant formula
| Study group | Role | What they receive |
|---|---|---|
| combination ARA+ DHA | Active comparator | combination 0.76% ARA+ 0.4% DHA in infant formula per day Receives: Dietary Supplement: combination ARA + DHA |
| DHA | Experimental | 0% ARA +0.4% DHA in infant formula per day Receives: Dietary Supplement: DHA |
What is being measured
The primary outcome is the main question the study is designed to answer.
total plasma fatty acid ARA levels
difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation
Measured: 6 months of supplementation
Secondary outcomes (6)
incidence of infections
record number, type and duration of infections
Measured: 6 months of supplementation
weight gain
differences between groups in weight gain (kg/d)
Measured: 6 months of supplementation
length gain
differences between groups in length gain (cm/d)
Measured: 6 months of supplementation
head circumference
differences between groups in head circumference (cm/d)
Measured: 6 months of supplementation
dietary intake of ARA
24 hour recall questionnaire
Measured: 6 months of supplementation
plasma levels of immune markers
cytokines and T cells levels in plasma will be measured
Measured: 6 months of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionMay 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SynteractHCR
- Responsible party
- Sponsor
- Investigators
- Ascension Marcos, PhD, Principal investigator, Instituto de Ciencia y Tecnología de Alimentos y Nutrición
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014115
- Sponsor's protocol ID
- 2015-1080
- Status last verified
- Jan 2020
- First submitted
- 3 Jan 2017
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF DIFFERENT ARA FORMULATIONS OF INFANT FORMULA ON FATTY ACID STATUS, IMMUNE MARKERS AND INFECTION RATES IN INFANTS
- ClinicalTrials.gov ID
- NCT03014115
- Acronym / sponsor ID
- 2015-1080
- Conditions
- Healthy Infants
- Keywords
- arachidonic, docosahexaenoic acid, infant formula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Collaborators
- SynteractHCR
- Study start
- Nov 2016
- Primary completion
- May 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination ARA+ DHA | Active comparator | Dietary Supplement: combination ARA + DHAcombination 0.76% ARA+ 0.4% DHA in infant formula per day |
| DHA | Experimental | Dietary Supplement: DHA0% ARA +0.4% DHA in infant formula per day |
Who may qualify
- Ages
- 22 to 26 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combination ARA + DHAAlso: infant formulacombination ARA + DHA supplemented infant formula | Dietary supplement | combination ARA+ DHA |
| DHAAlso: infant formulaDHA supplemented infant formula | Dietary supplement | DHA |
Primary outcome
total plasma fatty acid ARA levels
Time frame: 6 months of supplementation
difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation
6 secondary outcomes
incidence of infections
Time frame: 6 months of supplementation
weight gain
Time frame: 6 months of supplementation
length gain
Time frame: 6 months of supplementation
head circumference
Time frame: 6 months of supplementation
dietary intake of ARA
Time frame: 6 months of supplementation
plasma levels of immune markers
Time frame: 6 months of supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ascension Marcos, PhD principal investigator
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combination ARA + DHA and DHA in people with Healthy Infants, run by dsm-firmenich Switzerland AG at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total plasma fatty acid ARA levels (time frame: 6 months of supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.