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Oral Nutritional Supplementation in Children With Growth Concerns | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

Oral Nutritional Supplementation in Children With Growth Concerns

Oral Nutritional Supplementation in Children With Growth Concerns: A Randomized, Controlled Single-blinded Study

NCT07312201•Société des Produits Nestlé (SPN)

Summary

Multi-center, single-blinded, randomized, controlled study consisting of two arms, to investigate the impact of an oral nutritional supplement in combination with dietary counseling on growth in children with growth concerns as compared to children who receive dietary counselling alone

Eligibility

Age

2 - 3 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Child's parent(s) is of legal age of majority (18 years of age), must understand the informed consent form and other relevant study documents, and is willing and able to fulfill the requirements of the study protocol.
•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 aged 24 - 41 months at inclusion.
•Child is generally healthy (acute illnesses in a minor condition which are common in childhood such as viral or bacterial infections (e.g., conjunctivitis, otitis media, upper/lower respiratory tract infection, gastroenteritis, hand foot \& mouth disease) at time of enrolment is permitted).
•Children whose parents, caregivers, or guardians show some concern about their child's dietary intakes and growth, such as child is too thin for his or her height, or child has experienced recent rapid weight loss or failure to gain weight or height and child has a z-score for weight-for-age or weight-for-height or both parameters ≤ -1SD as per WHO growth charts.
•Child's parents agree to feed their child an oral nutritional supplement in addition to normal diet.
•Child's parent(s) / guardian can be contacted directly by telephone throughout the study.

Exclusion Criteria

•Child is currently breastfed or is consuming breast milk.
•Child is currently consuming or consumed in the past month growing-up milk / toddler formula. Growing-up milks / toddler formulas are products specifically formulated for young children and provide key macro- and micro-nutrients.
•Child is currently consuming or consumed in the past month oral nutrition supplement (ONS). The standard ONS formula has an energy density of at least 0.85 kcal/mL, containing protein, carbohydrate and/or fat, as well as a wide range of micronutrients to supplement or use as the sole source of nutrition.
•Child has known or suspected cows' milk protein intolerance / allergy, lactose intolerance, galactosemia, soy intolerance / allergy, fish oil intolerance / allergy, or allergy or intolerance to any ingredient in the study product.
•Child fed vegan, vegetarian, or vegetarian plus fish diets in which milk products are excluded.
•Underlying medical illness that could affect growth or feeding, such as gastrointestinal \[GI\] disorders (such as celiac disease, short bowel syndrome, maldigestion/malabsorption, significant GI malformations or surgery etc.); neurodevelopmental disability; chronic infections (such as tuberculosis or HIV infection); congenital disease or genetic disorders (such as congenital cardiac disease, Down syndrome, thalassemia); or other chronic illness that may impact growth or feeding according to the clinician opinion.
•Child is unable to consume foods or ONS orally (e.g. dysphagia, anorexia, difficulty in swallowing due to acquired or congenital abnormalities that would hamper oral intake of the study product.)
•Clinically significant nutritional deficiency requiring specific nutritional therapy other than the study product (for example tube feeding)
•Child has acute illness including acute viral infection, respiratory tract infection etc. even in a minor condition at time of enrolment. A child presenting with an acute illness can be re-screened at least two weeks after the episode of illness has resolved.
•Child has a z-score for weight-for-height or weight-for-age or height-for-age or any combination of these three parameters ≤ -3SD as per WHO growth charts.
+4 more criteria

Key Dates

Start Date

September 30, 2026

Primary Completion Date

March 31, 2028

Completion Date

May 31, 2028

Last Updated

December 31, 2025

Enrollment

216

ESTIMATED participants

Conditions

GrowthToddlersAttentionCognitive Function

Interventions

Nutrient dense oral nutritional supplement

DIETARY_SUPPLEMENT

Contacts

Renette Foo

CONTACT

+65 68905709 shufenrenette.foo@rd.nestle.com

Alison Petit-Jean

CONTACT

+41 216326193 alison.petit-jean@nestle.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Oral Nutritional Supplementation in Children With Growth Concerns

Inclusion Criteria

Exclusion Criteria

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