Malnutrition, ChildNCT05437068
Nutritional Supplementation in Children at Risk of Undernutrition
A study testing Oral Nutritional Supplement (ONS) in people with Malnutrition, Child, run by Abbott Nutrition.
Trial summary
This is a prospective, multicenter, single-arm intervention study. The expected duration of study participation for each participant is approximately 120 days. The current study aims to investigate the effectiveness of an ONS formula in children at risk or with undernutrition in Thailand. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Malnutrition, Child
- What is being tested?
- Oral Nutritional Supplement (ONS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2022to 11 Nov 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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child is between 1 year 0 days to 5 years 364 days old at enrolment
- Undernourished or at risk of undernutrition, defined as:
- WHZ <- 1 and HAZ <-1 for children up to 4 years 364 days, according to the WHO Growth Standards; or
- BMIAZ <-1 and HAZ <-1 for children 5 years 0 days and older, according to the WHO Growth Reference Standards
- Child is not currently breastfed
- Child's parent(s)/LG is willing to abstain from giving additional non-study Oral Nutritional Supplement (ONS) other than the study product during the study intervention period
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- Child is a singleton
- 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
- Child 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 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
- 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
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- Child has been diagnosed with the following:
- Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis
- 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)
- Any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study
About this study
Official title: Effects of Oral Nutritional Supplementation in 12-71 Months Old Children at Risk of Undernutrition
This is a prospective, multicenter, single-arm intervention study. The expected duration of study participation for each participant is approximately 120 days. The current study aims to investigate the effectiveness of an ONS formula in children at risk or with undernutrition in Thailand.
- Conditions
- Malnutrition, Child
- Being tested
- Oral Nutritional Supplement (ONS)
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Nutritional Supplement (ONS)Other
ONS plus 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 (ONS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height-for-age-Z-score
Change in Height-for-age-Z-score
Measured: Baseline to 120 days
Secondary outcomes (11)
Weight
Measured in Kg
Measured: Baseline to 30 days and 120 days
Height
Measured in cm
Measured: Baseline to 30 days and 120 days
Mid-Upper-Arm Circumference (MUAC)
Measured in cm
Measured: Baseline to 30 days and 120 days
Weight-for-Height Measurement Calculations
Weight-for-height standard z scores and percentiles
Measured: Baseline to 30 days and 120 days
Weight-for-Age Measurement Calculations
Weight-for-age standard z scores and percentiles
Measured: Baseline to 30 days and 120 days
BMI-for-Age Measurement Calculations
BMI-for-age standard z scores and percentiles
Measured: Baseline to 30 days and 120 days
Height-for-Age Measurement Calculations
Height-for-age standard z scores and percentiles
Measured: Baseline to 30 days and 120 days
MUAC-for-Age Measurement Calculations
MUAC-for-age standard z scores and percentiles
Measured: Baseline to 30 days and 120 days
Dietary Intake
Measured by 24-hour dietary recall
Measured: Baseline to 30 days and 120 days
Appetite
Visual analog scale from 0 (Ate Very Little) to 10 (Ate Very Much) with high scores being favorable
Measured: Baseline to 30 days and 120 days
Physical Activity
Visual analog scale from 0 (Not Active) to 10 (Very Active) with high scores being favorable
Measured: Baseline to 30 days and120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start11 Nov 2022
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Why it stopped: Change in research focus
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition, ChildStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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 Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437068
- Sponsor's protocol ID
- AL55
- Status last verified
- Feb 2023
- First submitted
- 15 Jun 2022
- Last updated
- 1 Mar 2023
- 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 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Nutritional Supplementation in 12-71 Months Old Children at Risk of Undernutrition
- ClinicalTrials.gov ID
- NCT05437068
- Acronym / sponsor ID
- AL55
- Conditions
- Malnutrition, Child
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in research focus
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 11 Nov 2022 (actual)
- First posted
- 29 Jun 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 is a prospective, multicenter, single-arm intervention study. The expected duration of study participation for each participant is approximately 120 days. The current study aims to investigate the effectiveness of an ONS formula in children at risk or with undernutrition in Thailand.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Nutritional Supplement (ONS) Group | Experimental | Other: Oral Nutritional Supplement (ONS)Two servings per day in addition to dietary counseling |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Child is between 1 year 0 days to 5 years 364 days old at enrolment
- WHZ <- 1 and HAZ <-1 for children up to 4 years 364 days, according to the WHO Growth Standards; or
- BMIAZ <-1 and HAZ <-1 for children 5 years 0 days and older, according to the WHO Growth Reference Standards
- Child is not currently breastfed
- Child's parent(s)/LG is willing to abstain from giving additional non-study Oral Nutritional Supplement (ONS) other than the study product during the study intervention period
Key exclusion criteria (13 listed)
- Child 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 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
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 Supplement (ONS)ONS plus dietary counseling | Other | Oral Nutritional Supplement (ONS) Group |
Primary outcome
Height-for-age-Z-score
Time frame: Baseline to 120 days
Change in Height-for-age-Z-score
11 secondary outcomes
Weight
Time frame: Baseline to 30 days and 120 days
Height
Time frame: Baseline to 30 days and 120 days
Mid-Upper-Arm Circumference (MUAC)
Time frame: Baseline to 30 days and 120 days
Weight-for-Height Measurement Calculations
Time frame: Baseline to 30 days and 120 days
Weight-for-Age Measurement Calculations
Time frame: Baseline to 30 days and 120 days
BMI-for-Age Measurement Calculations
Time frame: Baseline to 30 days and 120 days
Height-for-Age Measurement Calculations
Time frame: Baseline to 30 days and 120 days
MUAC-for-Age Measurement Calculations
Time frame: Baseline to 30 days and 120 days
Dietary Intake
Time frame: Baseline to 30 days and 120 days
Appetite
Time frame: Baseline to 30 days and 120 days
Physical Activity
Time frame: Baseline to 30 days and120 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- 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 Nutrition
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nutritional Supplement (ONS) in people with Malnutrition, Child, run by Abbott Nutrition.
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 10 inclusion and 13 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: withdrawn, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Height-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?
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 1 Mar 2023.