NCT05911893

Brief Summary

The goal of this clinical trial is to investigate the effect of high caloric oral nutritional supplements on body proportion, weight, linear growth pattern, neuropsychological development level and related health aspects (gut health, immune function, quality of life, etc.) in participants aged 1 to 3 years who are malnourished (underweight and wasting),as well as to evaluate the safety of applying high caloric oral nutritional supplements. Participants will receive nutritional education and daily high caloric oral nutritional supplements(experimental group),or will receive nutritional education and dietary instruction(control group).This study may provide data to support the development of clinical intervention strategies for malnourished Chinese children.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

June 17, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2026

Completed
Last Updated

March 18, 2026

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

May 16, 2023

Last Update Submit

March 16, 2026

Conditions

Malnutrition, ChildMalnourishmentNutritional DeficiencyUndernutrition

Keywords

Oral Nutritional SupplementsPhysique GrowthNeuropsychological Development

Outcome Measures

Primary Outcomes (1)

  • BMI for Age Z-score(BAZ)

    Trained research assistants or health care practitioners obtain weight in kilograms and height in centimeters (mean of 3 consecutive measurements). Height and weight will be combined to report BMI in kg/m\^2.Then, the BAZ is calculated using WHO2011v3.2.2 software.

    at 6 months of enrollment

Secondary Outcomes (14)

  • Dietary Diary

    at 0, 1, 2, 3, 6 and 12 months of enrollment

  • BMI for Age Z-score(BAZ)

    at 0, 1, 2, 3 and 12 months of enrollment

  • Weight for Age Z-score(WAZ)

    at 0, 1, 2, 3, 6 and 12 months of enrollment

  • Height for Age Z-score(HAZ)

    at 0, 1, 2, 3, 6 and 12 months of enrollment

  • Gesell Developmental Scale Test

    at 0, 6, and 12 months of enrollment

  • +9 more secondary outcomes

Study Arms (2)

high caloric oral nutritional supplements group

EXPERIMENTAL

Participants aged 1 to 3 years who are malnourished (underweight and wasting). They will receive nutritional education,dietary instruction and daily high caloric oral nutritional supplements for 12 months.

Dietary Supplement: high caloric oral nutritional supplementsBehavioral: nutritional educationBehavioral: dietary guidance

nutritional education and dietary guidance group

ACTIVE COMPARATOR

Participants aged 1 to 3 years who are malnourished (underweight and wasting). They will receive nutrition education and dietary instruction.

Behavioral: nutritional educationBehavioral: dietary guidance

Interventions

high caloric oral nutritional supplementsDIETARY_SUPPLEMENT

High caloric oral nutritional supplements (which can supplement 30% of the energy requirement) is given daily, and the recommended amount of energy and protein is referred to the 2013 Chinese Dietary Nutrient Reference Intake Table. At 6 months of enrollment, participants will be asked to evaluate whether to continue feeding according to the experimental group protocol or to stop to ensure proper nutritional intake.

Also known as: high-energy total nutrition formula
high caloric oral nutritional supplements group
nutritional educationBEHAVIORAL

After enrollment,health education information is pushed approximately every 4 weeks through the WeChat platform or/and short text messages to parents.

high caloric oral nutritional supplements groupnutritional education and dietary guidance group
dietary guidanceBEHAVIORAL

At follow-up visits at 0, 1, 2, 3, 6,and 12 months after enrollment, a professionally trained pediatrician give the participant's guardian dietary instructions appropriate to the age stage and physical condition of the child. Each session lasts approximately 10 minutes.

high caloric oral nutritional supplements groupnutritional education and dietary guidance group

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 1-3 years
  • BMI for Age Z-score\<-2
  • Height-for-age z score\<-2
  • Total daily energy intake\<75% of recommended nutrient intake
  • The child's guardian is willing to participate in this study and sign an informed consent form.

You may not qualify if:

  • Chronic or severe infectious disease (e.g., chronic hepatitis, HIV or tuberculosis infection)
  • Certain congenital or genetic diseases affecting physical growth and development (congenital heart disease, Down's syndrome, infantile anorexia nervosa, etc.), malignancies and use of drugs (diuretics, appetite stimulants, steroids and growth hormones, etc.)
  • Severe gastrointestinal disorders (e.g., celiac disease, short bowel syndrome, inflammatory bowel disease, etc.)
  • Acute and chronic respiratory/digestive tract infections within 2 weeks prior to enrollment
  • Allergy or contraindication to any of the ingredients in the high-energy total nutrition formula used in this study
  • Have used high-energy enteral nutrition preparations for the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Anhui Provincial Children's Hospital

Hefei, Anhui, 230001, China

RECRUITING

Children's Hospital of The Capital Institute of Pediatrics

Beijing, Beijing Municipality, 100020, China

RECRUITING

The First Hospital of Jilin University

Jilin, Changchun, China

RECRUITING

Growth, Development and Mental health of Children and Adolescence Center

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510200, China

RECRUITING

Guiyang Maternity and Child Health Care Hospital

Guiyang, Guizhou, 550003, China

RECRUITING

Hunan Children's Hospital

Changsha, Hunan, 410007, China

RECRUITING

Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

RECRUITING

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, 330006, China

RECRUITING

Baoji Maternity and Child Healthcare Hospital

Baoji, Shanxi, 721000, China

RECRUITING

Xianyang Children's Hospital

Xianyang, Shanxi, 712000, China

RECRUITING

Chengdu Women's and Children's Central Hospital，School of Medicine，University of Electronic Science and Technology of China

Chengdu, Sichuan, 610091, China

RECRUITING

Kunming Children's Hospital

Kunming, Yunnan, 650000, China

RECRUITING

Related Publications (1)

  • Hemming K, Taljaard M, McKenzie JE, Hooper R, Copas A, Thompson JA, Dixon-Woods M, Aldcroft A, Doussau A, Grayling M, Kristunas C, Goldstein CE, Campbell MK, Girling A, Eldridge S, Campbell MJ, Lilford RJ, Weijer C, Forbes AB, Grimshaw JM. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ. 2018 Nov 9;363:k1614. doi: 10.1136/bmj.k1614.

    PMID: 30413417BACKGROUND

MeSH Terms

Conditions

Child Nutrition DisordersMalnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Li Chen, doctor

    Children's Hospital of Chongqing Medical University

    STUDY DIRECTOR

Central Study Contacts

Li Chen, doctor

CONTACT

136 7762 0103chenli2012@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants aged 1 to 3 years who are malnourished (underweight and wasting) are randomly divided into an experimental group and a control group. The experimental group is given nutritional education and high-energy total nutrition formula, while the control group is given nutritional education and dietary guidance. At the 1-month, 2-month, 3-month, and 6-month follow-ups of enrollment, children in the control group are transferred to the trial group if the assessment revealed that they are unable to achieve ≥75% of their predicted nutritional requirements through dietary modification or their rate of weight gain do not improve, according to the study design principles of the stepped wedge cluster trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Director

Study Record Dates

First Submitted

May 16, 2023

First Posted

June 22, 2023

Study Start

June 17, 2024

Primary Completion

March 10, 2026

Study Completion

March 10, 2026

Last Updated

March 18, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Data is confidential during the study.

Locations

CN(13)