NCT05911893 the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children
| NCT ID | NCT05911893 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Chongqing Medical University |
| Condition | Malnutrition, Child |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-06-17 |
| Primary Completion | 2026-03-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-06-17 with a primary completion date of 2026-03-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 & Investigator
Li Chen, doctor
STUDY DIRECTOR
Children's Hospital of Chongqing Medical University
Frequently Asked Questions
Who can join the NCT05911893 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 3 Years, studying Malnutrition, Child. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05911893 currently recruiting?
Yes, NCT05911893 is actively recruiting participants. Contact the research team at chenli2012@126.com for enrollment information.
Where is the NCT05911893 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Jilin City, China, Chongqing, China and 9 additional locations.
Who is sponsoring the NCT05911893 clinical trial?
NCT05911893 is sponsored by Children's Hospital of Chongqing Medical University. The principal investigator is Li Chen, doctor at Children's Hospital of Chongqing Medical University. The trial plans to enroll 200 participants.