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OpenTrials
Completed

NCT Number: NCT04766346

Nutritional Supplementation in Children Aged 1-3 Years Experiencing Growth Concerns

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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Key information

Conditions

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Las Piñas Doctors Hospital

Las Piñas, 1742, Philippines

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 age 12 - 36 months and generally healthy (acute illness in a minor condition which are common in childhood such as viral or bacterial infection e.g. conjunctivitis, otitis media, upper/lower respiratory tract infection, gastroenteritis, hand foot & mouth disease at time of enrolment is permitted).
  • Children whose parents show some concern about their child's growth, such as child is too thin for his or her length/height, child has experienced recent rapid weight loss or failure to gain weight or length/height, or child's growth curve shows a downward trajectory of growth velocity
  • Child has a weight-for-length/height ≤ 25th percentile as per WHO growth charts.
  • Parents agree to feed their child a nutritional supplement in addition to normal diet.
  • Child's parent(s) / guardian can be contacted directly by telephone or email throughout the study.
  • Child's parent is of legal age of consent, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol.

Exclusion criteria

  • Child is currently breastfed or is consuming breast milk
  • Child has known or suspected cows' milk protein intolerance / allergy, lactose intolerance, soy intolerance / allergy, fish oil intolerance / allergy, or other food allergies that impact diet.
  • Child fed vegan, vegetarian, or vegetarian plus fish diets in which milk products are excluded
  • Child has chronic illness or other disease including any condition that impacts feeding or growth
  • Child having any congenital malformation (e.g., gastrointestinal tract atresia) or surgery sequelae (e.g., short bowel syndrome) potentially affecting feeding or growth
  • Child has been diagnosed with Infantile anorexia nervosa
  • Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study.
  • Child or child's parent(s) not willing and/or not able to comply with scheduled visits and the requirements of the study protocol.
  • Child of any investigational site staff member or Nestlé employee directly involved in the conduct of the trial.
  • Child is currently participating in or has participated in another clinical trial within 4 weeks prior to enrolment.

Treatment and study plan

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.

Primary outcomes

  1. The primary objective of this clinical trial is to to assess the effect of NS on weight gain and linear growth.

    Time frame: Day 1 to Day 113

    The primary endpoint is the change in weight-for-length/height z-score

Secondary outcomes

  1. Weight

    Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113

    Measurement of Weight in grams

  2. Length/height

    Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113

    Measurement of length/height in cms

  3. Triceps skin fold thickness

    Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113

    Measurement of triceps skinfold thickness

  4. Sub-scapular skinfold thickness

    Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113

    Measurement of sub-scapular skinfold thickness in mm

  5. Suprailiac skinfold thickness

    Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113

    Measurement of suprailiac skinfold thickness in mm

  6. BMI

    Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113

    BMI will be calculated and expressed in Kg/m2

  7. Z scores and percentiles

    Time frame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113

    • 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
  8. Nutrient intake

    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

  9. Learning skills

    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)

  10. Temperament and behavior

    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.

  11. Child and parent well-being reported from the parents' perspective

    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.

  12. Product acceptance

    Time frame: Day 22, Day 64, Day 113

    Product acceptance scores from the Toddler Milk Satisfaction Questionnaire

  13. Product acceptance including child-liking and post-ingestive effects

    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

Other outcomes

  1. Safety assessment

    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.

  2. Sick days

    Time frame: Day -7 to Day 113 + 30

    Total number of sick days

  3. Concomittant medications and treatment

    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.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Nutritional Supplementation in Children Aged 1-3 Years Experiencing Growth Concerns: a Prospective, Single-arm, Open-label, Interventional Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2021
Registry last updated
Nov 28, 2022

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.

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