Your session is about to expire
← Back to Search
Nutritional Supplement
Oral Nutritional Supplements for Malnutrition in Children
N/A
Waitlist Available
Research Sponsored by Abbott Nutrition
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Child is 36 months - 107 months of age
Be younger than 18 years old
Must not have
Child has been diagnosed with severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis
Child has been diagnosed with clinically significant nutritional deficiency requiring specialty nutritional therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 120 days
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if giving undernourished children a nutrient-rich drink along with healthy eating advice helps them grow better and become stronger.
Who is the study for?
This trial is for undernourished children aged 3-107 months in the U.S. whose caregivers agree to avoid non-study supplements and follow study procedures. Children with a normal height-for-age score, regular ONS use, acute infections, severe gastrointestinal disorders, hemoglobin disorders, or other significant medical conditions are excluded.
What is being tested?
The trial tests if taking a pediatric oral nutritional supplement (ONS) plus dietary counseling over 120 days improves growth and nutrition in undernourished children compared to just dietary counseling alone. It's randomized: some kids will get the ONS; others won't.
What are the potential side effects?
Potential side effects aren't specified but could include reactions to ingredients in the ONS for those with allergies or intolerances. Regular monitoring should identify any adverse effects from the supplement.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 3 and 9 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My child has a severe gastrointestinal disorder like celiac disease.
Select...
My child needs special nutrition due to a significant deficiency.
Select...
My child has a diagnosed blood disorder affecting hemoglobin.
Select...
My child has infantile anorexia, a developmental disability like cerebral palsy, or a severe developmental delay.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 120 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 120 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Weight-for-age z-score (WAZ)
Secondary study objectives
Anthropometric Measurement Calculations
Appetite
Dietary Diversity
+3 moreOther study objectives
Activity Data
Adverse Event Reporting
Caregiver Opinion Questionnaire
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Oral Nutritional Supplement (ONS) GroupExperimental Treatment2 Interventions
Two servings per day in addition to dietary counseling
Group II: Control GroupExperimental Treatment1 Intervention
dietary counseling
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Oral nutritional supplements (ONS) work by providing a concentrated source of essential nutrients, including vitamins, minerals, proteins, and calories, which may be lacking in a malnourished patient's diet. These supplements support growth, improve nutritional status, and address nutrient deficiencies.
For malnutrition patients, this is crucial as it promotes weight gain, enhances physical and cognitive development, and stabilizes overall health outcomes.
Find a Location
Who is running the clinical trial?
Abbott NutritionLead Sponsor
169 Previous Clinical Trials
33,283 Total Patients Enrolled
30 Trials studying Malnutrition
16,289 Patients Enrolled for Malnutrition
Jennifer Williams, MPHStudy ChairAbbott Nutrition
6 Previous Clinical Trials
641 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child has a condition like cancer, liver, heart issues, Down's syndrome that affects growth.My child has a severe gastrointestinal disorder like celiac disease.My child has been diagnosed with an infection such as a cold, diarrhea, hepatitis, HIV, or TB.My child is willing to take the study product throughout the study.My child needs special nutrition due to a significant deficiency.My child has a diagnosed blood disorder affecting hemoglobin.My child has infantile anorexia, a developmental disability like cerebral palsy, or a severe developmental delay.My child is between 3 and 9 years old.My child's caregiver agrees not to give any non-study oral supplements during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Oral Nutritional Supplement (ONS) Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger