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

NCT ID: NCT04766346

Last Updated: 2022-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-26
• Study Completion Date: 2022-10-27

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Nutritional Supplement

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

Group Type: EXPERIMENTAL

Fortified Cow's Milk-Based Oral Nutritional Supplement

Intervention Type: 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.

Interventions

Fortified Cow's Milk-Based Oral Nutritional Supplement

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Las Piñas Doctors Hospital

Las Piñas, , Philippines

Countries

Philippines

Other Identifiers

20.09.INF

Identifier Type: -

Identifier Source: org_study_id