UndernutritionNCT05239208
Effects of Oral Nutritional Supplementation in Children at Risk of Undernutrition
A study testing Oral Nutrition Supplement (ONS) Group in people with Undernutrition, run by Abbott Nutrition at 1 site in Vietnam.
Trial summary
This prospective, randomized, controlled study will evaluate the effects of oral nutritional supplementation plus dietary counseling versus dietary counseling alone in children at nutritional risk. Read more about this study
- Who is it for?
- Ages 24 to 60 months
- Conditions the study is for
- Undernutrition
- What is being tested?
- Oral Nutrition Supplement (ONS) Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteVietnam
- Study dates
- 14 Jan 2022to 18 Dec 2022
- 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 24 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 24-60 months old
- Undernourished or at risk of undernutrition according to the WHO Growth Standards.
- Child's parent(s)/legal guardian (LG) is willing to abstain from giving additional non-study ONS other than the study product during the study intervention period.
- Child's parent(s)/LG is able and willing to follow study procedures and record data in parent diary and complete any forms or assessments needed throughout the study.
- Child's parent(s)/LG is not planning to relocate during the study period.
- Child's parent(s)/LG has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) or other applicable privacy regulation authorization prior to any participation in the study.
Who cannot join
- Participant participates in another study that has not been approved as a concomitant study.
- Child is known to have galactosemia, be allergic or intolerant to any ingredient found in the study product.
- Child is currently drinking an Abbott product(s).
- Child had a history of preterm delivery, defined as a birth before 37 completed weeks of gestation as reported by parent(s)/LG.
- Child had birth weight < 2500 g or > 4000 g.
- Child whose either parent has BMI ≥ 27.5 kg/m2
Show all 15Show fewer
- Child has continuous oral nutrition supplement (ONS) usage for at least 15 days in the past 1 month prior to screening. The standard ONS formula usually has an energy density of at least 1 kcal/mL, containing protein, carbohydrate and/or fat, as well as a wide range of micronutrients to supplement or use as the sole source of nutrition.
- Child has current acute or chronic infections including but not restricted to respiratory infections, diarrhea, acute and chronic Hepatitis B or C, HIV infection or tuberculosis.
- Child has been diagnosed with the following according to medical records or report by parent(s)/LG or the clinician's judgment:
- Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic (Exception: Intestinal parasites infection)
- Neoplastic, renal, hepatic or cardiovascular, hormonal or metabolic disorders, congenital disease or genetic disorders such as atrial or ventricular wall defects, Down's syndrome, or thalassemia
- Infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or developmental delay
- Disorders of hemoglobin structure, function or synthesis
- Clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product) as diagnosed by the investigator.
- 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
1 site in 1 country.
About this study
Official title: Effects of Oral Nutritional Supplementation With Dietary Counseling in 24-60 Months Old Children at Risk of Undernutrition
This prospective, randomized, controlled study will evaluate the effects of oral nutritional supplementation plus dietary counseling versus dietary counseling alone in children at nutritional risk.
- Conditions
- Undernutrition
- Being tested
- Oral Nutrition Supplement (ONS) Group, Control Group
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Nutrition Supplement (ONS) GroupOther
Oral nutritional supplement specifically designed for nutritionally-at risk children and dietary counseling
Control GroupOther
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 Nutrition Supplement (ONS) Group |
| Control Group | Active comparator | Dietary counseling Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight-for-Age Z-Score
Change in weight-for-age z-score
Measured: Baseline to 120 Days
Secondary outcomes (9)
Weight
Measured in Kg
Measured: Baseline to 240 Days
Height
Measured in cm
Measured: Baseline to 240 Days
Mid-Upper-Arm Circumference (MUAC)
Measured in cm
Measured: Baseline to 240 Days
Weight-for-Height Measurement Calculations
Weight-for-height standard z-scores and percentiles
Measured: Baseline to 240 Days
BMI-for-Age Measurement Calculations
BMI-for-age standard z-scores and percentiles
Measured: Baseline to 240 Days
Height-for-Age Measurement Calculations
Height-for-age standard z-scores and percentiles
Measured: Baseline to 240 Days
MUAMC Measurement Calculations
Mid-upper-arm-circumference-for-age standard z-scores and percentiles
Measured: Baseline to 240 Days
Dietary Intake
Measured by 24-hour dietary recall
Measured: Baseline to 240 Days
Appetite
Visual analog scale from Ate Very Little to Ate Very Much
Measured: Baseline to 240 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start14 Jan 2022
- Primary completion18 Dec 2022
- Study completion18 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yen Ling Mandy Ow, PhD, Study chair, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239208
- Sponsor's protocol ID
- AL45
- Status last verified
- Feb 2023
- First submitted
- 7 Jan 2022
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ow MYL, Tran NT, Berde Y, Nguyen TS, Tran VK, Jablonka MJ, Baggs GE, Huynh DTT. Efficacy of long-term oral nutritional supplementation with dietary counseling on growth, body composition and bone mineralization in children with or at risk for undernutrition: a randomized controlled trial. Nutr J. 2025 Jul 14;24(1):110. doi: 10.1186/s12937-025-01133-5.
PubMed 40660276
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Nutritional Supplementation With Dietary Counseling in 24-60 Months Old Children at Risk of Undernutrition
- ClinicalTrials.gov ID
- NCT05239208
- Acronym / sponsor ID
- AL45
- Conditions
- Undernutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 18 Dec 2022 (actual)
- Study completion
- 18 Dec 2022 (actual)
- First posted
- 14 Feb 2022 (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.
This prospective, randomized, controlled study will evaluate the effects of oral nutritional supplementation plus dietary counseling versus dietary counseling alone in children at nutritional risk.
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 Nutrition Supplement (ONS) GroupTwo servings per day in addition to dietary counseling |
| Control Group | Active comparator | Other: Control GroupDietary counseling |
Who may qualify
- Ages
- 24 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children 24-60 months old
- Undernourished or at risk of undernutrition according to the WHO Growth Standards.
- Child's parent(s)/legal guardian (LG) is willing to abstain from giving additional non-study ONS other than the study product during the study intervention period.
- Child's parent(s)/LG is able and willing to follow study procedures and record data in parent diary and complete any forms or assessments needed throughout the study.
- Child's parent(s)/LG is not planning to relocate during the study period.
Key exclusion criteria (15 listed)
- Participant participates in another study that has not been approved as a concomitant study.
- Child is known to have galactosemia, be allergic or intolerant to any ingredient found in the study product.
- Child is currently drinking an Abbott product(s).
- Child had a history of preterm delivery, defined as a birth before 37 completed weeks of gestation as reported by parent(s)/LG.
- Child had birth weight < 2500 g or > 4000 g.
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 Nutrition Supplement (ONS) GroupOral nutritional supplement specifically designed for nutritionally-at risk children and dietary counseling | Other | Oral Nutritional Supplement (ONS) Group |
| Control GroupDietary counseling | Other | Control Group |
Primary outcome
Weight-for-Age Z-Score
Time frame: Baseline to 120 Days
Change in weight-for-age z-score
9 secondary outcomes
Weight
Time frame: Baseline to 240 Days
Height
Time frame: Baseline to 240 Days
Mid-Upper-Arm Circumference (MUAC)
Time frame: Baseline to 240 Days
Weight-for-Height Measurement Calculations
Time frame: Baseline to 240 Days
BMI-for-Age Measurement Calculations
Time frame: Baseline to 240 Days
Height-for-Age Measurement Calculations
Time frame: Baseline to 240 Days
MUAMC Measurement Calculations
Time frame: Baseline to 240 Days
Dietary Intake
Time frame: Baseline to 240 Days
Appetite
Time frame: Baseline to 240 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 28 Feb 2023.
- Derived from this study: PubMed 40660276Ow MYL, Tran NT, Berde Y, Nguyen TS, Tran VK, Jablonka MJ, Baggs GE, Huynh DTT. Efficacy of long-term oral nutritional supplementation with dietary counseling on growth, body composition and bone mineralization in children with or at risk for undernutrition: a randomized controlled trial. Nutr J. 2025 Jul 14;24(1):110. doi: 10.1186/s12937-025-01133-5.
- 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.
Yen Ling Mandy Ow, PhD study chair
Abbott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nutrition Supplement (ONS) Group in people with Undernutrition, run by Abbott Nutrition at 1 site in Vietnam.
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 15 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 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. 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 (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?
On the ClinicalTrials.gov record for NCT05239208, which also lists 1 linked publication.
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 28 Feb 2023.