GrowthNCT04766346
Nutritional Supplementation in Children Aged 1-3 Years Experiencing Growth Concerns
A study testing Fortified Cow's Milk-Based Oral Nutritional Supplement in people with Growth and Learning, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
Trial summary
This open-label clinical trial will gain evidence of the effect of an oral Nutritional Supplement (NS) to help improve catch-up growth and support learning skills in children with growth concerns. Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- What is being tested?
- Fortified Cow's Milk-Based Oral Nutritional Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 sitePhilippines
- Study dates
- 26 Feb 2021to 27 Oct 2022
- 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 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Evidence of a personally signed and dated informed consent document indicating that the child's parent(s) / legally acceptable representative (LAR) has been informed of all pertinent aspects of the study.
- Child was full-term at birth (i.e., ≥ 37 completed weeks of gestation with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg).
- Child is age 12 - 36 months and generally healthy (acute illness in a minor condition which are common in childhood such as viral or bacterial infection e.g. conjunctivitis, otitis media, upper/lower respiratory tract infection, gastroenteritis, hand foot \& mouth disease at time of enrolment is permitted).
- Children whose parents show some concern about their child's growth, such as child is too thin for his or her length/height, child has experienced recent rapid weight loss or failure to gain weight or length/height, or child's growth curve shows a downward trajectory of growth velocity
- Child has a weight-for-length/height ≤ 25th percentile as per WHO growth charts.
- Parents agree to feed their child a nutritional supplement in addition to normal diet.
- Child's parent(s) / guardian can be contacted directly by telephone or email throughout the study.
- Child's parent is of legal age of consent, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol.
Who cannot join
- Child is currently breastfed or is consuming breast milk
- Child has known or suspected cows' milk protein intolerance / allergy, lactose intolerance, soy intolerance / allergy, fish oil intolerance / allergy, or other food allergies that impact diet.
- Child fed vegan, vegetarian, or vegetarian plus fish diets in which milk products are excluded
- Child has chronic illness or other disease including any condition that impacts feeding or growth
- Child having any congenital malformation (e.g., gastrointestinal tract atresia) or surgery sequelae (e.g., short bowel syndrome) potentially affecting feeding or growth
- Child has been diagnosed with Infantile anorexia nervosa
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- Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study.
- Child or child's parent(s) not willing and/or not able to comply with scheduled visits and the requirements of the study protocol.
- Child of any investigational site staff member or Nestlé employee directly involved in the conduct of the trial.
- Child is currently participating in or has participated in another clinical trial within 4 weeks prior to enrolment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Supplementation in Children Aged 1-3 Years Experiencing Growth Concerns: a Prospective, Single-arm, Open-label, Interventional Study
This open-label clinical trial will gain evidence of the effect of an oral Nutritional Supplement (NS) to help improve catch-up growth and support learning skills in children with growth concerns.
- Being tested
- Fortified Cow's Milk-Based Oral Nutritional Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified Cow's Milk-Based Oral Nutritional SupplementOther
The NS is a fortified cow's milk-based product provided in powdered form that provides the appropriate amount of energy and protein to promote growth in children.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Supplement | Experimental | The NS is a fortified cow's milk-based product provided in powdered form. Receives: Other: Fortified Cow's Milk-Based Oral Nutritional Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this clinical trial is to to assess the effect of NS on weight gain and linear growth.
The primary endpoint is the change in weight-for-length/height z-score
Measured: Day 1 to Day 113
Secondary outcomes (13)
Weight
Measurement of Weight in grams
Measured: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Length/height
Measurement of length/height in cms
Measured: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Triceps skin fold thickness
Measurement of triceps skinfold thickness
Measured: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Sub-scapular skinfold thickness
Measurement of sub-scapular skinfold thickness in mm
Measured: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Suprailiac skinfold thickness
Measurement of suprailiac skinfold thickness in mm
Measured: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
BMI
BMI will be calculated and expressed in Kg/m2
Measured: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Z scores and percentiles
- Sex-age-specific weight, length/height, BMI and triceps and subscapular skinfold thickness percentiles and Z-scores calculated according to WHO standards. 2) Changes from baseline in sex-age-specific percentiles and Z-scores
Measured: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Nutrient intake
Nutrient intake from 3-day Food Intake Diaries that will be completed at home for two weekdays and 1 weekend day
Measured: Day 22, Day 43, Day 113
Learning skills
Learning Scores derived from the Ages and Stages Questionnaire, Third Edition (ASQ-3) (with a focus on communication and problem-solving skills)
Measured: Day 1, Day 113
Temperament and behavior
Temperament and behaviour scores from the Early Childhood Behavior Questionnaire- Short Form (ECBQ-SF) completed. The ECBQ-SF has 107 questions and assesses dimensions of temperament such as activity Level/Energy, attentional Focusing, attentional Shifting, cuddliness, discomfort, fear, frustration, high-intensity Pleasure, impulsivity, inhibitory Control, low-intensity Pleasure, motor Activation, perceptual Sensitivity, positive Anticipation, sadness, shyness, sociability and soothability.The scale items ask parents to report on the frequency of specific behaviours in frequently occurring contexts on a 7 point likert scale ranging from never to always.
Measured: Day 1, Day 113
Child and parent well-being reported from the parents' perspective
Child health-related quality of life scores assessed using the Infant and Toddler Quality of Life Questionnaire Short Form (ITQOL-SF47). The ITQOL-SF47 has 47 questions and assesses domains such as the overall health, physical abilities, growth and development, bodily pain/discomfort, temperament and moods, general health perceptions, parent impact - emotional, parent impact - time and family cohesion with a score of 0 (worst) to 100 (best) for each of these domains.
Measured: Day 1, Day 113
Product acceptance
Product acceptance scores from the Toddler Milk Satisfaction Questionnaire
Measured: Day 22, Day 64, Day 113
Product acceptance including child-liking and post-ingestive effects
Primary facial expression valence and child heart rate variability derived from the ANURA for Research (smartphone app) while child is consuming one serving of the NS
Measured: Day 22, Day 64, Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start26 Feb 2021
- Primary completion16 Aug 2022
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GrowthStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766346
- Sponsor's protocol ID
- 20.09.INF
- Status last verified
- Nov 2022
- First submitted
- 16 Dec 2020
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Supplementation in Children Aged 1-3 Years Experiencing Growth Concerns: a Prospective, Single-arm, Open-label, Interventional Study
- ClinicalTrials.gov ID
- NCT04766346
- Acronym / sponsor ID
- 20.09.INF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 23 Feb 2021 (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 open-label clinical trial will gain evidence of the effect of an oral Nutritional Supplement (NS) to help improve catch-up growth and support learning skills in children with growth concerns.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional Supplement | Experimental | Other: Fortified Cow's Milk-Based Oral Nutritional SupplementThe NS is a fortified cow's milk-based product provided in powdered form. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Evidence of a personally signed and dated informed consent document indicating that the child's parent(s) / legally acceptable representative (LAR) has been informed of all pertinent aspects of the study.
- Child was full-term at birth (i.e., ≥ 37 completed weeks of gestation with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg).
- Child is age 12 - 36 months and generally healthy (acute illness in a minor condition which are common in childhood such as viral or bacterial infection e.g. conjunctivitis, otitis media, upper/lower respiratory tract infection, gastroenteritis, hand foot \& mouth disease at time of enrolment is permitted).
- Children whose parents show some concern about their child's growth, such as child is too thin for his or her length/height, child has experienced recent rapid weight loss or failure to gain weight or length/height, or child's growth curve shows a downward trajectory of growth velocity
- Child has a weight-for-length/height ≤ 25th percentile as per WHO growth charts.
Key exclusion criteria (10 listed)
- Child is currently breastfed or is consuming breast milk
- Child has known or suspected cows' milk protein intolerance / allergy, lactose intolerance, soy intolerance / allergy, fish oil intolerance / allergy, or other food allergies that impact diet.
- Child fed vegan, vegetarian, or vegetarian plus fish diets in which milk products are excluded
- Child has chronic illness or other disease including any condition that impacts feeding or growth
- Child having any congenital malformation (e.g., gastrointestinal tract atresia) or surgery sequelae (e.g., short bowel syndrome) potentially affecting feeding or growth
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 |
|---|---|---|
| Fortified Cow's Milk-Based Oral Nutritional SupplementThe NS is a fortified cow's milk-based product provided in powdered form that provides the appropriate amount of energy and protein to promote growth in children. | Other | Nutritional Supplement |
Primary outcome
The primary objective of this clinical trial is to to assess the effect of NS on weight gain and linear growth.
Time frame: Day 1 to Day 113
The primary endpoint is the change in weight-for-length/height z-score
13 secondary outcomes
Weight
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Length/height
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Triceps skin fold thickness
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Sub-scapular skinfold thickness
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Suprailiac skinfold thickness
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
BMI
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Z scores and percentiles
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Nutrient intake
Time frame: Day 22, Day 43, Day 113
Learning skills
Time frame: Day 1, Day 113
Temperament and behavior
Time frame: Day 1, Day 113
Child and parent well-being reported from the parents' perspective
Time frame: Day 1, Day 113
Product acceptance
Time frame: Day 22, Day 64, Day 113
Product acceptance including child-liking and post-ingestive effects
Time frame: Day 22, Day 64, Day 113
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 28 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortified Cow's Milk-Based Oral Nutritional Supplement in people with Growth and Learning, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
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 8 inclusion and 10 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 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. 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?
The primary objective of this clinical trial is to to assess the effect of NS on weight gain and linear growth. (time frame: Day 1 to Day 113). 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 28 Nov 2022.