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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
216
The ONS is provided in powdered form that provides the appropriate amount of protein, vitamins and minerals
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
Weight of growing children
Measurement of weight will be in grams
Time frame: Day -7 to Day 169
Length/height of growing children
Measurement of length/height will be in centimetres (cms)
Time frame: Day -7 to Day 169
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
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
Z-scores and percentiles
Change from baseline in sex-age-specific percentiles and z-scores
Time frame: Day -7 to Day 169
Nutrient intake of children
Paper-based 24-hour dietary recall administered by a trained dietitian on-site
Time frame: Day 1 to Day 169
Bone mass index of children
Bone density will be measured in z-scores
Time frame: Day 1 to Day 169
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Physical strength of children
The grip strength will be measured in kilograms (kg)
Time frame: Day 1 to Day 169
Skeletal muscle mass of children
Urine sample will be collected in millimetres during the study (mL)
Time frame: Day 1 to Day 169
Blood marker of longitudinal growth
Blood sample will be collected during the study in microlitres (μL)
Time frame: Day 1 to Day 169
Blood markers of bone turnover
Blood sample will be collected during the study in microlitres (μL)
Time frame: Day 1 to Day 169
Blood markers of nutritional status
Blood sample will be collected during the study in microlitres (μL)
Time frame: Day 1 to Day 169
Cognitive Functioning
Questionnaire will be administered by the site staff for assessment
Time frame: Day 169
Product satisfaction of children and parents
Questionnaire will be administered by the site staff for assessment
Time frame: Day 14 to Day 169
Parental perceptions on appetite, growth, level of activity and sleep of children
Questionnaire will be administered by site staff for assessment
Time frame: Day 1 to Day 169
Safety assessment (Adverse Events)
Time frame: Day -7 to Day 169
Duration of illness and absence from pre-school due to illness
Time frame: Time Frame: Day -7 to Day 169
Concomitant medications and treatments
Time frame: Day -7 to Day 169