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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional Supplement | Experimental | The NS is a fortified cow's milk-based product provided in powdered form. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fortified Cow's Milk-Based Oral Nutritional Supplement | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this clinical trial is to to assess the effect of NS on weight gain and linear growth. | The primary endpoint is the change in weight-for-length/height z-score | Day 1 to Day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Measurement of Weight in grams | Day 1, Day 22, Day 43, Day 64, Day 85, Day 113 |
| Length/height | Measurement of length/height in cms |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment | 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. | Day -7 to Day 113 + 30 |
| Sick days |
INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Las Piñas Doctors Hospital | Las Piñas | 1742 | Philippines |
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| Day 1, Day 22, Day 43, Day 64, Day 85, Day 113 |
| Triceps skin fold thickness | Measurement of triceps skinfold thickness | Day 1, Day 22, Day 43, Day 64, Day 85, Day 113 |
| Sub-scapular skinfold thickness | Measurement of sub-scapular skinfold thickness in mm | Day 1, Day 22, Day 43, Day 64, Day 85, Day 113 |
| Suprailiac skinfold thickness | Measurement of suprailiac skinfold thickness in mm | Day 1, Day 22, Day 43, Day 64, Day 85, Day 113 |
| BMI | BMI will be calculated and expressed in Kg/m2 | Day 1, Day 22, Day 43, Day 64, Day 85, Day 113 |
| Z scores and percentiles | 1) Sex-age-specific weight, length/height, BMI and triceps and subscapular skinfold thickness percentiles and Z-scores calculated according to WHO standards. 2) Changes from baseline in sex-age-specific percentiles and Z-scores | Day 1, Day 22, Day 43, Day 64, Day 85, Day 113 |
| Nutrient intake | Nutrient intake from 3-day Food Intake Diaries that will be completed at home for two weekdays and 1 weekend day | Day 22, Day 43, Day 113 |
| Learning skills | Learning Scores derived from the Ages and Stages Questionnaire, Third Edition (ASQ-3) (with a focus on communication and problem-solving skills) | Day 1, Day 113 |
| Temperament and behavior | 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. | Day 1, Day 113 |
| Child and parent well-being reported from the parents' perspective | 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. | Day 1, Day 113 |
| Product acceptance | Product acceptance scores from the Toddler Milk Satisfaction Questionnaire | Day 22, Day 64, Day 113 |
| Product acceptance including child-liking and post-ingestive effects | 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 | Day 22, Day 64, Day 113 |
Total number of sick days
| Day -7 to Day 113 + 30 |
| Concomittant medications and treatment | 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. | Day -7 to Day 113 + 30 |