InfantsDHANCT05266677
DHA Proof-of-Concept Study in Infants and Toddlers
A study testing blend of glycerides at certain proportions and glycerides used in current formulas in people with Infants and Toddlers, run by Société des Produits Nestlé (SPN).
Trial summary
This is a prospective, double blind, randomized, controlled proof-of-concept study with a parallel group design that aims to investigate the effect of a liquid oral supplement comprising a blend of glycerides at certain proportions on infant and toddler DHA status. Read more about this study
- Who is it for?
- Ages 2 to 14 monthsHealthy volunteers can take part
- Conditions the study is for
- Infants, Toddlers, Nutritional Supplement
- What is being tested?
- blend of glycerides at certain proportions and glycerides used in current formulas
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to May 2023
- 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 2 to 14 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who fulfil all of the following inclusion criteria will be included:
- Evidence of personally signed and dated informed consent form indicating that the infant/toddler's parent(s)/ Legally Authorized representative (LAR) has been informed of all pertinent aspects of the study.
- Infants/toddlers whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
- Infants/toddlers must meet the following inclusion criteria respectively to be eligible for enrollment into the study:
- Healthy normally developing infant/toddler at the discretion of the investigator.
- Healthy term infant (37-42 weeks of gestation) at birth.
Show all 10Show fewer
- At enrollment visit, post-natal age 2-3 months (60-90 days) for infants or 13-14 months for toddlers (date of birth = day 0).
- For the infant group, infants must have been exclusively consuming and tolerating a cow's milk infant formula not containing DHA for the past month, and their parent(s)/LAR must have independently elected, before enrolment, not to breastfeed.
- For the toddler group, toddlers must have been consuming and tolerating a cow's milk TMS not containing DHA for the past month.
- Infants or toddlers must not have been consuming DHA-containing supplements for the past month.
Who cannot join
- Any of the following criteria would render a subject ineligible for inclusion:
- Infants/toddlers with conditions requiring feedings other than those specified in the protocol.
- Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 grams (g) per day of complementary foods or liquids at enrollment.
- Infants/toddlers who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
- Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
- Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).
Show all 12Show fewer
- Evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal (e.g., complicated gastroesophageal reflux combined with inadequate growth and/or respiratory complications, Hirschsprung's disease), or other systemic diseases.
- History of admission to the Neonatal Intensive Care Unit, with the exception of admission for jaundice phototherapy.
- Currently participating or having participated in another clinical trial since birth.
- Other severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant/toddler inappropriate for entry into the study.
- Infants/toddlers who are presently receiving or have received prior to enrollment any of the following: medication(s) or supplement(s) which are known or suspected to affect fat digestion, absorption, and/or metabolism (e.g., lactase enzymes, pancreatic enzymes); medications that may neutralize or suppress gastric acid secretion; medications that could affect any study outcomes.
- Infants/toddlers whose parent(s)/LAR who in the Investigator's assessment cannot be expected to comply with the protocol or with study procedures.
About this study
Official title: Effect of a Liquid Oral Supplement Comprising a Blend of Glycerides at Certain Proportions on Infant and Toddler DHA Status
This is a prospective, double blind, randomized, controlled proof-of-concept study with a parallel group design that aims to investigate the effect of a liquid oral supplement comprising a blend of glycerides at certain proportions on infant and toddler DHA status.
- Conditions
- Infants, Toddlers, Nutritional Supplement
- Being tested
- blend of glycerides at certain proportions, glycerides used in current formulas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blend of glycerides at certain proportionsOther
combination of glycerides in specific proportions in a liquid oral supplement
glycerides used in current formulasOther
glycerides used in current formulas in a liquid oral supplement
| Study group | Role | What they receive |
|---|---|---|
| EXPL | Experimental | Liquid oral supplement comprising a blend of glycerides at certain proportions Receives: Other: blend of glycerides at certain proportions |
| CTRL | Other | Liquid oral supplement comprising glycerides used in current formulas Receives: Other: glycerides used in current formulas |
What is being measured
The primary outcome is the main question the study is designed to answer.
RBC-DHA levels after 56 days of supplementation
Red blood cell (RBC)-DHA after eight weeks of intervention
Measured: Study day 56
Secondary outcomes (8)
RBC, plasma additional fatty acids status
Determination of omega-3, omega-6, eicosapentanoic acid, arachidonic acid
Measured: Study days 0, 14, 28 and 56
DHA supplement intake
Parent-reported supplement intake assessed using a 3-day DHA Supplement Intake and Tolerance Diary
Measured: Study days 3, 14, 28 and 56
Gastrointestinal (GI) tolerance
Parent-reported GI tolerance indicators assessed using a 3-day DHA Supplement Intake and Tolerance Diary
Measured: Study days 3, 14, 28 and 56
Weight
Weight measured in grams
Measured: Study days 0, 14, 28 and 56
Length
Length measured in cm
Measured: Study days 0, 14, 28 and 56
Head circumference
Head circumference measured in cm
Measured: Study days 0, 14, 28 and 56
Dietary intakes of DHA and other fatty acids (toddler population only)
Assessed using a 24-hour food recall
Measured: Study days 0, 28 and 56
Standard adverse events (AEs) and serious AEs (SAEs) reporting for safety assessment
Incidence of AEs / SAEs reported throughout the study, particular attention will be paid to AEs related to GI tolerance and comfort
Measured: Study days 0, 14, 28, 56, and 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study startJul 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMay 2023 (estimated)
Why it stopped: Foreseen high level of subject burden and non compliance in the clinical trial due to extensive product preparation and the nutritional concept for the improvement of RBC DHA is compromised by the change in the product formulation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfantsStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elvira M Estorninos, MD, Principal investigator, Las Pinas Doctors Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266677
- Sponsor's protocol ID
- 18.20.NRC
- Acronym
- DHA
- Status last verified
- Jul 2022
- First submitted
- 4 Jan 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Liquid Oral Supplement Comprising a Blend of Glycerides at Certain Proportions on Infant and Toddler DHA Status
- ClinicalTrials.gov ID
- NCT05266677
- Acronym / sponsor ID
- DHA / 18.20.NRC
- Conditions
- Infants, Toddlers, Nutritional Supplement
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Foreseen high level of subject burden and non compliance in the clinical trial due to extensive product preparation and the nutritional concept for the improvement of RBC DHA is compromised by the change in the product formulation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jul 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 4 Mar 2022 (actual)
- 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.
This is a prospective, double blind, randomized, controlled proof-of-concept study with a parallel group design that aims to investigate the effect of a liquid oral supplement comprising a blend of glycerides at certain proportions on infant and toddler DHA status.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPL | Experimental | Other: blend of glycerides at certain proportionsLiquid oral supplement comprising a blend of glycerides at certain proportions |
| CTRL | Other | Other: glycerides used in current formulasLiquid oral supplement comprising glycerides used in current formulas |
Who may qualify
- Ages
- 2 to 14 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Evidence of personally signed and dated informed consent form indicating that the infant/toddler's parent(s)/ Legally Authorized representative (LAR) has been informed of all pertinent aspects of the study.
- Infants/toddlers whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
- Infants/toddlers must meet the following inclusion criteria respectively to be eligible for enrollment into the study:
Key exclusion criteria (12 listed)
- Infants/toddlers with conditions requiring feedings other than those specified in the protocol.
- Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 grams (g) per day of complementary foods or liquids at enrollment.
- Infants/toddlers who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
- Infants/toddlers who are presently receiving or have received prior to enrollment any of the following: medication(s) or supplement(s) which are known or suspected to affect fat digestion, absorption, and/or metabolism (e.g., lactase enzymes, pancreatic enzymes); medications that may neutralize or suppress gastric acid secretion; medications that could affect any study outcomes.
- Infants/toddlers whose parent(s)/LAR who in the Investigator's assessment cannot be expected to comply with the protocol or with study procedures.
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 |
|---|---|---|
| blend of glycerides at certain proportionscombination of glycerides in specific proportions in a liquid oral supplement | Other | EXPL |
| glycerides used in current formulasglycerides used in current formulas in a liquid oral supplement | Other | CTRL |
Primary outcome
RBC-DHA levels after 56 days of supplementation
Time frame: Study day 56
Red blood cell (RBC)-DHA after eight weeks of intervention
8 secondary outcomes
RBC, plasma additional fatty acids status
Time frame: Study days 0, 14, 28 and 56
DHA supplement intake
Time frame: Study days 3, 14, 28 and 56
Gastrointestinal (GI) tolerance
Time frame: Study days 3, 14, 28 and 56
Weight
Time frame: Study days 0, 14, 28 and 56
Length
Time frame: Study days 0, 14, 28 and 56
Head circumference
Time frame: Study days 0, 14, 28 and 56
Dietary intakes of DHA and other fatty acids (toddler population only)
Time frame: Study days 0, 28 and 56
Standard adverse events (AEs) and serious AEs (SAEs) reporting for safety assessment
Time frame: Study days 0, 14, 28, 56, and 70
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Infants
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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.
Elvira M Estorninos, MD principal investigator
Las Pinas Doctors Hospital
Questions about this trial
What is this clinical trial studying?
A study testing blend of glycerides at certain proportions and glycerides used in current formulas in people with Infants and Toddlers, run by Société des Produits Nestlé (SPN).
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 10 inclusion and 12 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: withdrawn, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
RBC-DHA levels after 56 days of supplementation (time frame: Study day 56). 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 Jul 2022.