UndernutritionNCT05161000
Oral Nutritional Supplementation in Children at Risk of Undernutrition
A study testing Oral Nutritional Supplement and Dietary counseling in people with Undernutrition, run by Abbott Nutrition at 17 sites in United States.
Trial summary
The objective of this randomized, controlled trial is to evaluate the effects of consuming a pediatric oral nutritional supplement (ONS) plus dietary counseling for 120 days on anthropometric growth, strength, and nutritional status, compared with dietary counseling alone in undernourished children in the United… Read more about this study
- Who is it for?
- Ages 36 to 107 months
- Conditions the study is for
- Undernutrition
- What is being tested?
- Oral Nutritional Supplement and Dietary counseling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 17 sitesUnited States
- Study dates
- 18 Apr 2022to 11 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 107 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child is 36 months - 107 months of age.
- 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.
- Child is willing to consume the study product for the duration of the study, if randomized to intervention group
Who cannot join
- Child has a height-for-age z-score ≥ 0.
- Child is currently drinking an oral nutritional supplement (ONS) on a regular basis (≥ 15 days in the past month)
- Child is participating in another study that has not been approved as a concomitant study by AN.
- Child has been diagnosed with the following:
- Galactosemia, or an allergy or intolerance to any ingredient found in the study product
- Acute or chronic infections including but not restricted to respiratory infections, diarrhea, Hepatitis B or C, HIV infection or tuberculosis
Show all 12Show fewer
- Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis
- Neoplastic, renal, hepatic or cardiovascular, hormonal or metabolic disorders, Down's syndrome or significant, uncorrected cardiac anomalies that may impact growth
- Infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or a developmental delay that is considered too severe for participation
- Disorders of hemoglobin structure, function or synthesis
- Clinically significant nutritional deficiency requiring specialty nutritional therapy
- Any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Velocity Clinical Research
Covington, Louisiana, 70433
Javara, Inc. 3377
Dallas, Texas, 75230
Proactive Clinical Research
Edinburg, Texas, 78539
HealthStar Research Glenwood
Glenwood, Arkansas, 71943
Tribe Clinical Research LLC.
Greenville, South Carolina, 29607
HealthStar Research, LLC
Hot Springs, Arkansas, 71913
Kissimmee Clinical Research
Kissimmee, Florida, 34743
Alivation Research (Primary Care)
Lincoln, Nebraska, 68526
L.A. Universal Research Center, Inc.
Los Angeles, California, 90057
Dade Research Center, LLC
Miami, Florida, 33126
D&H National Research Centers
Miami, Florida, 33155
Suncoast Research, Assoc., LLC
Miami, Florida, 33173
Midway Medical Clinic
Oneonta, Alabama, 35121
Springs Medical Research
Owensboro, Kentucky, 42303
Gentle Pediatrics
Sugar Land, Texas, 77479
Javara Inc. 3380
Winston-Salem, North Carolina, 27103
Southern Clinical Research
Zachary, Louisiana, 70791
About this study
Official title: Effects of Oral Nutritional Supplementation With Dietary Counseling in Children at Risk of Undernutrition
The objective of this randomized, controlled trial is to evaluate the effects of consuming a pediatric oral nutritional supplement (ONS) plus dietary counseling for 120 days on anthropometric growth, strength, and nutritional status, compared with dietary counseling alone in undernourished children in the United States.
- Conditions
- Undernutrition
- Being tested
- Oral Nutritional Supplement, Dietary counseling
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Nutritional SupplementOther
ONS plus dietary counseling
Dietary counselingOther
dietary counseling
| Study group | Role | What they receive |
|---|---|---|
| Oral Nutritional Supplement (ONS) Group | Experimental | Two servings per day in addition to dietary counseling Receives: Other: Oral Nutritional Supplement; Other: Dietary counseling |
| Control Group | Other | dietary counseling Receives: Other: Dietary counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight-for-age z-score (WAZ)
Change in weight-for-age z-score
Measured: baseline to 120 days
Secondary outcomes (6)
Anthropometric Measurement Calculations
Standard z-scores and percentiles including weight-for-age, height-for-age, weight-for-height, BMI-for-age and mid-upper-arm-circumference-for-age
Measured: baseline to 120 days
Mid-upper-arm circumference (MUAC)
Measured in cm
Measured: baseline to 120 days
Weight
Measured in Kg
Measured: baseline to 120 days
Height
Measured in cm
Measured: baseline to 120 days
Dietary Diversity
Measured by 24-hour dietary recall
Measured: baseline to 120 days
Appetite
Visual analog scale from Ate Very Little to Ate A Lot
Measured: baseline to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start18 Apr 2022
- Primary completion11 Jun 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndernutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Williams, MPH, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161000
- Sponsor's protocol ID
- AL48
- Status last verified
- Jul 2024
- First submitted
- 3 Dec 2021
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Nutritional Supplementation With Dietary Counseling in Children at Risk of Undernutrition
- ClinicalTrials.gov ID
- NCT05161000
- Acronym / sponsor ID
- AL48
- Conditions
- Undernutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this randomized, controlled trial is to evaluate the effects of consuming a pediatric oral nutritional supplement (ONS) plus dietary counseling for 120 days on anthropometric growth, strength, and nutritional status, compared with dietary counseling alone in undernourished children in the United States.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Nutritional Supplement (ONS) Group | Experimental | Other: Oral Nutritional Supplement, Other: Dietary counselingTwo servings per day in addition to dietary counseling |
| Control Group | Other | Other: Dietary counselingdietary counseling |
Who may qualify
- Ages
- 36 to 107 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child is 36 months - 107 months of age.
- 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.
Key exclusion criteria (12 listed)
- Child has a height-for-age z-score ≥ 0.
- Child is currently drinking an oral nutritional supplement (ONS) on a regular basis (≥ 15 days in the past month)
- Child is participating in another study that has not been approved as a concomitant study by AN.
- Child has been diagnosed with the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Nutritional SupplementONS plus dietary counseling | Other | Oral Nutritional Supplement (ONS) Group |
| Dietary counselingdietary counseling | Other | Control Group, Oral Nutritional Supplement (ONS) Group |
Primary outcome
Weight-for-age z-score (WAZ)
Time frame: baseline to 120 days
Change in weight-for-age z-score
6 secondary outcomes
Anthropometric Measurement Calculations
Time frame: baseline to 120 days
Mid-upper-arm circumference (MUAC)
Time frame: baseline to 120 days
Weight
Time frame: baseline to 120 days
Height
Time frame: baseline to 120 days
Dietary Diversity
Time frame: baseline to 120 days
Appetite
Time frame: baseline to 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Williams, MPH study chair
Abbott Nutrition
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nutritional Supplement and Dietary counseling in people with Undernutrition, run by Abbott Nutrition at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight-for-age z-score (WAZ) (time frame: baseline to 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.