Las Piñas Doctors Hospital
Las Piñas, 1742, Philippines
NCT Number: NCT04766346
This open-label clinical trial will gain evidence of the effect of an oral Nutritional Supplement (NS) to help improve catch-up growth and support learning skills in children with growth concerns.
Looking for future studies?
Notify MeHealthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The NS is a fortified cow's milk-based product provided in powdered form that provides the appropriate amount of energy and protein to promote growth in children.
Time frame: Day 1 to Day 113
The primary endpoint is the change in weight-for-length/height z-score
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Measurement of Weight in grams
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Measurement of length/height in cms
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Measurement of triceps skinfold thickness
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Measurement of sub-scapular skinfold thickness in mm
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Measurement of suprailiac skinfold thickness in mm
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
BMI will be calculated and expressed in Kg/m2
Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
Time frame: Day 22, Day 43, Day 113
Nutrient intake from 3-day Food Intake Diaries that will be completed at home for two weekdays and 1 weekend day
Time frame: Day 1, Day 113
Learning Scores derived from the Ages and Stages Questionnaire, Third Edition (ASQ-3) (with a focus on communication and problem-solving skills)
Time frame: Day 1, Day 113
Temperament and behaviour scores from the Early Childhood Behavior Questionnaire- Short Form (ECBQ-SF) completed. The ECBQ-SF has 107 questions and assesses dimensions of temperament such as activity Level/Energy, attentional Focusing, attentional Shifting, cuddliness, discomfort, fear, frustration, high-intensity Pleasure, impulsivity, inhibitory Control, low-intensity Pleasure, motor Activation, perceptual Sensitivity, positive Anticipation, sadness, shyness, sociability and soothability.The scale items ask parents to report on the frequency of specific behaviours in frequently occurring contexts on a 7 point likert scale ranging from never to always.
Time frame: Day 1, Day 113
Child health-related quality of life scores assessed using the Infant and Toddler Quality of Life Questionnaire Short Form (ITQOL-SF47). The ITQOL-SF47 has 47 questions and assesses domains such as the overall health, physical abilities, growth and development, bodily pain/discomfort, temperament and moods, general health perceptions, parent impact - emotional, parent impact - time and family cohesion with a score of 0 (worst) to 100 (best) for each of these domains.
Time frame: Day 22, Day 64, Day 113
Product acceptance scores from the Toddler Milk Satisfaction Questionnaire
Time frame: Day 22, Day 64, Day 113
Primary facial expression valence and child heart rate variability derived from the ANURA for Research (smartphone app) while child is consuming one serving of the NS
Time frame: Day -7 to Day 113 + 30
Data from standard AE reporting (including common illnesses) for safety assessment from date of ICF signing through 30 days after the last day of NS intake.
Time frame: Day -7 to Day 113 + 30
Total number of sick days
Time frame: Day -7 to Day 113 + 30
All concomitant medications / treatments used to treat illnesses and other conditions will be recorded (both dose and duration) through 30 days after the last day of NS intake.
Société des Produits Nestlé (SPN)
Industry
Nutritional Supplementation in Children Aged 1-3 Years Experiencing Growth Concerns: a Prospective, Single-arm, Open-label, Interventional Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07312201
Attention, Cognitive Function
View Trial DetailsNCT06312059
Growth
New York, United States
View Trial DetailsNCT04316221
Development; Delayed, Growth
Tecpán Guatemala, Departamento de Chimaltenango, Guatemala
View Trial DetailsNCT07302477
Adverse Event, Growth
Chak Four Hundred Fifty-four, Pakistan
View Trial Details