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

NCT04766346 | Completed

• 1 other identifier: 20.09.INF
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Growth; Learning; Toddlers

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• Weight

  Day 1, Day 22, Day 43, Day 64, Day 85, Day 113

• Length/height

  Day 1, Day 22, Day 43, Day 64, Day 85, Day 113

• Triceps skin fold thickness

  Day 1, Day 22, Day 43, Day 64, Day 85, Day 113

• Sub-scapular skinfold thickness

  Day 1, Day 22, Day 43, Day 64, Day 85, Day 113

• Suprailiac skinfold thickness

  Day 1, Day 22, Day 43, Day 64, Day 85, Day 113

Other Outcomes (3)

• Safety assessment

  Day -7 to Day 113 + 30

• Sick days

  Day -7 to Day 113 + 30

• Concomittant medications and treatment

  Day -7 to Day 113 + 30

Study Arms (1)

Nutritional Supplement

EXPERIMENTAL

The NS is a fortified cow's milk-based product provided in powdered form.

Other: Fortified Cow's Milk-Based Oral Nutritional Supplement

Interventions

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.

Nutritional Supplement

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Las Piñas Doctors Hospital

Las Piñas, 1742, Philippines

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: February 23, 2021
• Study Start: February 26, 2021
• Primary Completion: August 16, 2022
• Study Completion: October 27, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-11

Locations

PH (1)