Clinical trial NCT04766346: Nutritional Supplementation in Children Aged 1-3 Years Experiencing Growth Concerns
Official title: Nutritional Supplementation in Children Aged 1-3 Years Experiencing Growth Concerns: a Prospective, Single-arm, Open-label, Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth
Learning
Toddlers
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-02-23
Enrollment: 168
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: INCLUSION CRITERIA

1. 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.
2. 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).
3. 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).
4. 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
5. Child has a weight-for-length/height ≤ 25th percentile as per WHO growth charts.
6. Parents agree to feed their child a nutritional supplement in addition to normal diet.
7. Child's parent(s) / guardian can be contacted directly by telephone or email throughout the study.
8. 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

1. Child is currently breastfed or is consuming breast milk
2. 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.
3. Child fed vegan, vegetarian, or vegetarian plus fish diets in which milk products are excluded
4. Child has chronic illness or other disease including any condition that impacts feeding or growth
5. Child having any congenital malformation (e.g., gastrointestinal tract atresia) or surgery sequelae (e.g., short bowel syndrome) potentially affecting feeding or growth
6. Child has been diagnosed with Infantile anorexia nervosa
7. Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study.
8. Child or child's parent(s) not willing and/or not able to comply with scheduled visits and the requirements of the study protocol.
9. Child of any investigational site staff member or Nestlé employee directly involved in the conduct of the trial.
10. Child is currently participating in or has participated in another clinical trial within 4 weeks prior to enrolment.

Primary outcomes:
measure: The primary objective of this clinical trial is to to assess the effect of NS on weight gain and linear growth.
timeFrame: Day 1 to Day 113
Secondary outcomes:
measure: Weight
timeFrame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
measure: Length/height
timeFrame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
measure: Triceps skin fold thickness
timeFrame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
measure: Sub-scapular skinfold thickness
timeFrame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
measure: Suprailiac skinfold thickness
timeFrame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
measure: BMI
timeFrame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
measure: Z scores and percentiles
timeFrame: Day 1, Day 22, Day 43, Day 64, Day 85, Day 113
measure: Nutrient intake
timeFrame: Day 22, Day 43, Day 113
measure: Learning skills
timeFrame: Day 1, Day 113
measure: Temperament and behavior
timeFrame: Day 1, Day 113
measure: Child and parent well-being reported from the parents' perspective
timeFrame: Day 1, Day 113
measure: Product acceptance
timeFrame: Day 22, Day 64, Day 113
measure: Product acceptance including child-liking and post-ingestive effects
timeFrame: Day 22, Day 64, Day 113
Other outcomes:
measure: Safety assessment
timeFrame: Day -7 to Day 113 + 30
measure: Sick days
timeFrame: Day -7 to Day 113 + 30
measure: Concomittant medications and treatment
timeFrame: Day -7 to Day 113 + 30
Locations:
city: Las Piñas
country: Philippines
facility: Las Piñas Doctors Hospital
Study officials:
References: