Health TrialsbyHealthPanel

Oral Nutritional Supplementation in Children With Growth Concerns

ConditionsGrowthToddlersAttentionCognitive Function
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Nutrient dense oral nutritional supplement

    Dietary supplement

    The ONS is provided in powdered form that provides the appropriate amount of protein, vitamins and minerals

Treatment groups

216 Participants
are divided into 2 treatment groups
Group A: Experimental: Oral Nutritional Supplement (ONS) with Dietary CounsellingExperimental treatment 1 intervention
Group B: Control: Dietary CounsellingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Assess the effect of ONS coupled with dietary counseling on growth in children

Change in weight-for-age z score

Time frame
Day 1 to Day 169

Secondary outcomes

1

Weight of growing children

Measurement of weight will be in grams

Time frame
Day -7 to Day 169
2

Length/height of growing children

Measurement of length/height will be in centimetres (cms)

Time frame
Day -7 to Day 169
3

Mid-upper arm circumference of growing children

Measurement of mid-upper arm circumference will be in centimetres (cms)

Time frame
Day -7 to Day 169
4

Body mass index (BMI) of growing children

Calculated BMI will be in kilograms per square metre (kg/m²)

Time frame
Day -7 to Day 169

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Société des Produits Nestlé (SPN)

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: