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Oral Nutritional Supplements for Malnutrition in Children
Study Summary
This trial will compare the effects of consuming a pediatric oral nutritional supplement plus dietary counseling against dietary counseling alone in undernourished children in the United States.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Control Group
- Group 2: Oral Nutritional Supplement (ONS) Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Are there still slots available for volunteers in this experiment?
"Confirmed. Clinicaltrials.gov presents evidence that this research study is enrolling participants, with the original post date being April 18th 2022 and an update on August 2nd 2022."
For whom is this clinical trial open?
"This clinical trial seeks 200 participants, between the ages of three and nine years old who exhibit signs of nutritional deprivation. Participants must also satisfy additional criteria such as being willing to consume study product if randomized into intervention group, their caretaker is able and prepared to adhere to protocols while tracking information in parent diaries and completing any forms requested during the assessment period. Additionally, a signed informed consent form approved by an Institutional Review Board (IRB) along with Health Insurance Portability and Accountability Act (HIPAA) authorization have been obtained from each participant's guardian prior to commencement of the trial. Furthermore, non-study oral nutrition supplements are"
How many volunteers have been recruited for this clinical examination?
"Affirmative. Per the information available on clinicaltrials.gov, this research is actively looking for participants to join. It was first posted on April 18th 2022 and its most recent modification happened on August 2nd of the same year. The study requires 200 individuals from 10 distinct sites in order to be completed successfully."
Is the age bracket for this medical experiment limited to those under 30?
"To participate in the trial, patients must be between 3 and 8.75 years old. 55 participants who are under 18 will be studied while 80 seniors aged 65 or above are also welcome to join."
Are there numerous hospitals conducting this clinical experiment within the state?
"Presently, 10 clinical sites are on-boarding participants for this experiment. These facilities can be found in Glenwood, Kissimmee and Greenville among other cities; thus it's recommended to pick the closest one should you choose to join."
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