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the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children

Study acronym: EHCONSGDMC
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date changed from estimate of Dec 31, 2026 to Mar 10, 2026
    • Study completion date: Jun 30, 2027 to Mar 10, 2026
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Enrollment target: 800 to 200
    • Primary completion date: Feb 28, 2025 to Dec 31, 2026
    • Start date changed from estimate of Jun 30, 2023 to Jun 17, 2024
    • Study sites: 12 to 13
    • Study completion date: Jun 30, 2025 to Jun 30, 2027
    • Study description revised
    • Collaborators: 12 to 13
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05911893
Lead Sponsor Children's Hospital of Chongqing Medical University
Collaborators: Anhui Provincial Children's Hospital, Baoji Maternity and Child Healthcare Hospital, Chengdu Women's and Children's Central Hospital, Guiyang Maternity and Child Health Care Hospital, Guangzhou Women and Children's Medical Center, Hunan Children's Hospital, Jiangxi Maternal and Child Health Hospital, Kunming Children's Hospital, Nanjing Maternity and Child Health Care Hospital, Children's Hospital of The Capital Institute of Pediatrics, Xianyang Children's Hospital, Nestle Health Science, The First Hospital of Jilin University
Conditions
(from sponsor)		 Malnutrition, Child, Malnourishment, Nutritional Deficiency, Undernutrition
Related terms Child Nutrition Disorders, Malnutrition
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov