Oral Nutritional Supplementation in Children With Growth Concerns
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-41
SponsorSociété des Produits Nestlé (SPN)
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Nutrient dense oral nutritional supplement
Treatment groups
216 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov