CLINICAL TRIAL

Oral Nutritional Supplement for Under Nutrition

Recruiting · < 18 · All Sexes · Miami, FL

Oral Nutritional Supplementation in Children at Risk of Undernutrition

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About the trial for Under Nutrition

Eligible Conditions
Under Nutrition · Malnutrition

Treatment Groups

This trial involves 2 different treatments. Oral Nutritional Supplement is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Oral Nutritional Supplement
OTHER
Dietary counseling
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Child is undernourished as determined by BMI for age z-score or Mid-upper-arm circumference z-score
Child's caregiver has voluntarily signed and dated an informed consent form (ICF), approved by an IRB, and provided Health Insurance Portability and Accountability Act (HIPAA) or other applicable privacy regulation authorization prior to any participation in the study.
Child's caregiver is willing to abstain from providing non-study oral nutrition supplements during the study period duration.
Child's caregiver is able and willing to follow study procedures and record data in parent diaries and complete any forms or assessments needed during the study.
You have a normal child if you are aged 36 months to 107 months. show original
You are willing to consume the study product for the duration of the study, if randomized to intervention group. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: baseline to 120 days
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 120 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: baseline to 120 days.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Oral Nutritional Supplement will improve 1 primary outcome, 6 secondary outcomes, and 12 other outcomes in patients with Under Nutrition. Measurement will happen over the course of baseline to 120 days.

Child Eating Behavior Questionnaire
BASELINE TO 120 DAYS
35 questions 5-Point Likert Scale from Never to Always
BASELINE TO 120 DAYS
Dietary Diversity
BASELINE TO 120 DAYS
Measured by 24-hour dietary recall
BASELINE TO 120 DAYS
Hand Grip Strength
BASELINE TO 120 DAYS
Measured in kg
BASELINE TO 120 DAYS
Adverse Event Reporting
BASELINE TO 120 DAYS
Standard adverse event reporting
BASELINE TO 120 DAYS
Height
BASELINE TO 120 DAYS
Measured in cm
BASELINE TO 120 DAYS
Weight
BASELINE TO 120 DAYS
Measured in Kg
BASELINE TO 120 DAYS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get malnutrition a year in the United States?

More than 75% of Americans are undernourished at one time or another. At least 17% of women, and up to 22% of men, would qualify for a DDSS.

Anonymous Patient Answer

What is malnutrition?

Nutrition is the process by which individuals obtain the nutrients necessary to sustain or enhance life. As a term used to describe a pattern of under and over diets, it has been used for millennia by physicians to describe diseases. It is only recently that research has begun to fully comprehend the relationship between malnutrition and health. As more is learned about nutrition, this knowledge can aid in the advancement of public health and the understanding of health disparities in our society. Knowledge at the intersection of nutritional science and public health is currently lacking. In fact, studies show that there are few schools of nutritional practitioners in the United States, although there are numerous colleges and universities. There is also a paucity of research in this area with some schools more involved in nutrition than others.

Anonymous Patient Answer

What are common treatments for malnutrition?

In developing countries, nutrition management strategies often focus on the treatment of the child's or patient's hunger. As a result, treatment options are often in short supply, and often rely on limited budgets. For example, only 11 percent of pediatric nutrition services are based at academic medical centers in developing countries. When choosing a treatment, practitioners should consider the likelihood of success, and the need for support, as well as the resource-stiffest area for which services can best maximize patient care.\n

Anonymous Patient Answer

What are the signs of malnutrition?

Malnutrition is commonly associated with other signs and symptoms, including the presentation of the three hallmark symptoms. Clinicians often seek for additional signs and symptoms to help determine the underlying cause of a patient's nutritional status. In the absence of appropriate investigations and clinical signs and symptoms to determine the presence of malnutrition, an evaluation for other possible causes, including an assessment for the extent of illness or the extent to which underlying disease may be contributing to the patient's nutritional status, may help identify the underlying causes of malnutrition.

Anonymous Patient Answer

Can malnutrition be cured?

As this was an open-label pilot study and we do not know the long-term effects of nutritional rehabilitation, we cannot confirm if this nutritional intervention can be included in routine management for short-term malnutrition. We were however able to show if it is possible to improve BMI, LBM and MAC (body mass index, lean body mass and bioelectrical impedance) values in Malnourished patients with RHD in a short time frame, at least in the short term.

Anonymous Patient Answer

What causes malnutrition?

Factors like socioeconomic factors, cultural changes, health system failures, and environmental deterioration play important roles in the prevalence of childhood malnutrition. Strategies to prevent these contributing factors, together with improved health initiatives, are urgently required in order to overcome childhood malnutrition.

Anonymous Patient Answer

Has dietary counseling proven to be more effective than a placebo?

In a recent study, findings are in line with other studies and show that intervention had only moderate effects on most of the dietary patterns. However, it should be recognized that the control group in this study was not receiving the same counseling from the general practitioner as the intervention group was.

Anonymous Patient Answer

What is the latest research for malnutrition?

The treatment options for malnutrition are limited. Clinicians should be aware that patients' lives can be improved in a multidisciplinary setting by incorporating their nutritional concerns in an appropriate fashion. The goal is to minimize complications and maximize functional independence for the patient. Nutrition is an integral part of supportive care; however, a systematic approach addressing all components of malnutrition is essential to improving patients' quality of life.

Anonymous Patient Answer

What does dietary counseling usually treat?

Dietary counseling as used by a multidisciplinary team will relieve or eliminate discomfort associated with any degree of malnutrition by demonstrating adherence and improved knowledge of specific requirements of the patient. This will ultimately allow the patient to make choices about food choices without fear of having to take pills to self-medicate.

Anonymous Patient Answer

What are the latest developments in dietary counseling for therapeutic use?

Nutritional intervention of hospitalized children has emerged over the decades. Therapeutic intervention programs are often targeted at improving health-related quality of life. A meta-analysis on this subject indicates that nutritional intervention is not cost-effective and results in adverse effects for some patients.

Anonymous Patient Answer

Have there been any new discoveries for treating malnutrition?

Although a variety of new compounds and compounds with novel mechanisms of action are being synthesized, there has been little new evidence to aid in the development of new pharmaceutical products for treatment of malnourishment. This may be because most new drugs suffer from a poor oral bioavailability or suffer poor absorption in the small intestine.

Anonymous Patient Answer

Is dietary counseling typically used in combination with any other treatments?

Results from a recent paper demonstrate that both dietary counseling and antimalnutrition therapies are not typically used in combination with any other treatment. More studies with longer follow-up of participants who are on conventional anti-CNS therapies are needed. Future studies with larger numbers of participants would be needed to validate these findings.

Anonymous Patient Answer
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