Oral Nutritional Supplementation in Children With Growth Concerns

Nestlé

Status: Begins enrollment in 7 months

Conditions: Cognitive Function; Attention; Toddlers; Growth

Treatments: Dietary Supplement: Nutrient dense oral nutritional supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT07312201

2304INF

Details and patient eligibility

About

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

Enrollment: 216 estimated patients

Sex: All

Ages: 24 to 41 months old

Volunteers: Accepts Healthy Volunteers

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.
• Children currently receiving or having received prior to enrolment medication which are known to impact growth including systemic steroids, growth hormone and insulin
• Child or child's parent(s) not willing and/or not able to comply with scheduled visits and/or have plans to relocate to a different geographical location from the study location during the study period.
• 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 design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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216 participants in 2 patient groups

Experimental: Oral Nutritional Supplement (ONS) with Dietary Counselling

Experimental group

Description:

The ONS is a nutrient dense oral nutritional supplement provided in powdered form, coupled with dietary counselling conducted by a trained dietitian over a 24-week period.

Treatment:

Dietary Supplement: Nutrient dense oral nutritional supplement

Control: Dietary Counselling

No Intervention group

Description:

Dietary counselling conducted by a trained dietitian over a 24-week period